- EU approval of Revolade expands treatment options for pediatric patients aged 1 year and above with chronic ITP who have not responded to other therapies
- Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may not be able to swallow tablets
- For about one in four children with ITP, a disorder of low blood platelet count and potential bleeding, the condition becomes chronic[1],[2]
BASEL, 08-Apr-2016 — /EuropaWire/ — Novartis announced today that the European Commission (EC) has approved Revolade® (eltrombopag) for the treatment of pediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). The approval includes the use of tablets as well as a new oral suspension formulation of Revolade, which is designed for younger children who may not be able to swallow tablets. Revolade was approved by the EC in 2010 for use in adults with the same condition.
“For the families and caregivers of children affected by a rare disease, having a new treatment option can be game-changing in managing the disease,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.
ITP is a rare blood disorder that affects about five in 100,000 children each year and is characterized by a low platelet count[2],[3]. Because people with ITP have a low number of platelets, they may bruise easily and experience bleeding that is hard to stop[2]. Chronic ITP, defined as ongoing disease more than 12 months after diagnosis[4], occurs in 13-36% of children with ITP[1]. A small number of pediatric patients with chronic ITP may be at risk of significant bleeding[5].
The approval is based on data from two double-blind, randomized, placebo-controlled trials, including the largest Phase III clinical trial in this patient population. In these studies, patients in the treatment and placebo arms were permitted to use some stable maintenance ITP therapies, per local treatment practices. Treatment with Revolade significantly increased and sustained platelet counts among pediatric patients with chronic ITP who were refractory to or had relapsed after prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids.
The EC approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein.
Revolade is a once-daily oral thrombopoietin (TPO) receptor agonist that works by inducing stimulation and differentiation of megakaryocytes (large cells, found especially in bone marrow) from bone marrow stem cells to increase platelet production[6]. In August 2015, the US Food and Drug Administration (FDA) approved a new oral suspension formulation, which expanded use of eltrombopag (marketed as Promacta® in the USA) to include children 1 year of age and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
About the PETIT and PETIT2 clinical trials
PETIT is a Phase II, multi-center, three-part study to investigate the efficacy, safety and tolerability of Revolade in pediatric patients (ages 1 to 17 years) with previously treated chronic ITP. The trial included patients living with ITP for six months or longer who had a platelet count <30 Gi/L. Part one was an open label, dose finding study; part two was double-blind and placebo-controlled, and part three was an open-label extension. Patients in the study were permitted to use some stable maintenance ITP therapies, per local treatment practices. The primary efficacy outcome, which was percentage of participants who achieved a platelet count >=50 Gi/L without rescue therapy at least once between weeks one and six, was met by 62% and 32% of patients in the Revolade arm and the control arm, respectively (p=0.011). The secondary efficacy endpoint analyses demonstrated clinically meaningful benefit in terms of decreased need for rescue treatment (13% of patients on Revolade compared to 50% of patients in the control arm). Patients received Revolade for a total of six months during the trial[6],[7].
PETIT2 is a Phase III, multi-center, two-part study to investigate the efficacy, safety and tolerability of Revolade in pediatric patients (ages 1 to 17 years) with previously treated chronic ITP. The trial included patients living with chronic ITP for 12 months or longer who also had a platelet count <30 Gi/L. Part one was randomized, double-blind and placebo-controlled and part two was an open-label extension. Patients in the study were permitted to use some stable maintenance ITP therapies, per local treatment practices. The primary efficacy outcome, which was percentage of participants who achieved a platelet count >=50 Gi/L without rescue therapy for at least six out of eight weeks between weeks five and 12 of part one of the study, was met by 40% of patients treated with Revolade and 3% of patients in the control arm (p<0.001). This result was consistent across the age cohorts. The secondary efficacy endpoint analyses demonstrated clinically meaningful benefit in terms of decreased need for rescue treatment (19% of patients on Revolade compared to 24% of patients in the control arm) during the randomized, double-blind period. Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the trial. In the open label eltrombopag-only period, 15 of 87 patients were taking concomitant ITP medications at baseline. Of these 15 patients, eight (53%) had a sustained reduction or permanent discontinuation of at least one baseline ITP medication (seven patients permanently discontinued and one patient had sustained reduction for >=18 weeks). Patients received Revolade for a total of nine months during the trial[6],[8].
In both studies, safety was consistent with the known safety profile of Revolade in chronic ITP in adults and the population under study. No new safety signals were detected. The most common adverse reactions in pediatric chronic ITP patients 1 year and older (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis[6],[7],[8].
About chronic ITP
ITP is a blood disorder characterized by blood that does not clot as it should due to a low number of platelets. People who have ITP often have purple bruises or tiny red or purple dots on the skin. They also may have nosebleeds, bleeding from the gums during dental work, or other bleeding that’s hard to stop. In most cases, an autoimmune response is thought to cause ITP in which a person’s immune system attacks and destroys its own platelets[2].
The two types of ITP are acute (temporary or short-term) and chronic (long-lasting). Acute ITP mainly occurs in children, often after a viral infection, and generally lasts less than six months. The platelet count returns to normal within six to 12 months and treatment may not be needed[2]. Chronic ITP, defined as ongoing disease more than 12 months after diagnosis[4], occurs in 13-36% of children with ITP[1]. A small number of pediatric patients with chronic ITP may be at risk of significant bleeding[5].
The goal of treatment in chronic ITP for children is to maintain a safe platelet count that reduces the risk of bleeding[2]. The most commonly available and used therapies-corticosteroids and intravenous immunoglobulin (IVIG)-are associated with side effects that are often difficult to tolerate in a pediatric setting[5],[9],[10].
About Revolade® (eltrombopag)
Revolade is approved in more than 100 countries worldwide for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an inadequate response or are intolerant to other treatments. Eltrombopag (marketed as Promacta® in the USA), is approved by the US Food and Drug Administration for once-daily use in pediatric patients 1 year and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Revolade is also approved in over 45 countries worldwide for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. In September 2015, the European Commission approved Revolade for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant.
Revolade Important Safety Information
Revolade may cause serious side effects, such as liver problems, high platelet counts and a higher chance for blood clots, bleeding after stopping treatment, and bone marrow problems.
Revolade may damage the liver and cause serious, even life threatening, illness. Blood tests to check the liver are needed before taking Revolade and during treatment. When certain antiviral treatments are given together with Revolade for the treatment of thrombocytopenia due to hepatitis C virus (HCV) infections, some liver problems can get worse.
A doctor will order the blood tests and any other tests required. In some cases Revolade treatment may need to be stopped. Patients should tell a doctor right away if they have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, unusual tiredness, right upper stomach area pain.
Patients have a higher chance of getting a blood clot if their platelet count is too high during treatment with Revolade, but blood clots can occur with normal or even low platelet counts. Patients who have cirrhosis of the liver are at risk of a blood clot in a blood vessel that feeds the liver. Patients may have severe complications from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. A doctor will check the patient’s blood platelet counts, and change the dose or stop Revolade if platelet counts get too high. Patients should tell their doctor right away if they have signs and symptoms of a blood clot in the leg, such as swelling or pain/tenderness of one leg.
When patients with chronic ITP stop taking Revolade, their blood platelet count will drop back down to what it was before they started taking Revolade. These effects are most likely to happen within 4 weeks after patients stop taking Revolade. The lower platelet counts may increase risk of bleeding. A doctor will check platelet counts for at least 4 weeks after patients stop taking Revolade. Patients should tell their doctor or pharmacist if they have any bruising or bleeding after they stop taking Revolade.
Patients being treated for the disease may have problems with their bone marrow. Medicines like Revolade could make this problem worse. Signs of bone marrow changes may show up as abnormal results in blood tests. A doctor may also carry out tests to directly check the bone marrow during treatment with Revolade.
The most common side effects of Revolade when used to treat adult patients with chronic ITP include headache, anemia, decreased appetite, insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and peripheral edema.
The most common side effects of Revolade when used to treat pediatric patients with chronic ITP include upper respiratory tract infection, nasopharyngitis, cough, diarrhea, pyrexia, rhinitis, abdominal pain, oropharyngeal pain, toothache, rash, increased AST and rhinorrhea.
The most common side effects of Revolade when used to treat patients with chronic HCV and antiviral agents include headache, anemia, decreased appetite, insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and peripheral edema.
The most common side effects of Revolade when used to treat patients with severe aplastic anemia (SAA) include headache, dizziness, insomnia, cough, dyspnea, oropharyngeal pain, rhinorrhea, nausea, diarrhea, abdominal pain, transaminases increased, ecchymosis, arthralgia, muscle spasms, pain in extremity, fatigue, febrile neutropenia, and pyrexia. Common side effects that may show up in blood tests include increase in some liver enzymes and laboratory tests that may show abnormal changes to the cells in the bone marrow.
Please see full EU Summary of Product Characteristics for Revolade (eltrombopag).
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as “can,” “may,” “goal,” “will,” or similar terms, or by express or implied discussions regarding potential new indications or labeling for Revolade (eltrombopag), new formulations of Revolade, or regarding potential future revenues from Revolade. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Revolade will be submitted or approved for any additional indications, labeling or formulations in any market, or at any particular time. Nor can there be any guarantee that Revolade will be commercially successful in the future. In particular, management’s expectations regarding Revolade could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis(link is external).
References
[1] George JN, Woolf SH, Raskob GE. Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood. 1996;88(1):3-40.
[2] Immune Thrombocytopenia. US National Institutes of Health website. http://www.nhlbi.nih.gov/book/export/html/4917(link is external). Accessed February 1, 2016.
[3] Fogarty PF, Segal JB. The epidemiology of immune thrombocytopenic purpura. Curr Opin Hematol. 2007;14(5):515-519.
[4] Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113(11):2386-2393.
[5] Neunert C, Lim W, Crowther M, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207.
[6] Revolade Summary of Product Characteristics.
[7] Bussel JB, Garcia de Miguel P, Despotovic JM, et al. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015; published online July 29, 2015.
[8] Grainger JD, Locatelli F, Chotsampancharoen T, et al. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. Lancet. 2015; published online July 29, 2015.
[9] Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115(2):168-186.
[10] Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med. 2002;346(13):995-1008.
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- Amadeus unveils five defining trends for the US group travel and events industry in 2022
- On World Bipolar Day ALCEDIAG announces EIT Health supported EDIT-B Consortium validating innovative blood diagnostic test for bipolar disorder
- Global & Europe Mental Health Software and Devices Market to Witness a Revenue of USD 13367.12 Million by 2030 by Growing with a CAGR of 13.28% During 2021-2030; Increasing Concern for Mental Health Disorders to Drive Market Growth
- Digi Communications NV announces the release of the 2021 Preliminary Financial Results
- Digi Communications NV announces Investors Call for the 2021 Preliminary Financial Results presentation
- At MWC in Barcelona, Amphenol will be exhibiting its wide offering for wireless service providers – including Open RAN compatible active 5G antennas
- ELIOS combined with cataract surgery delivers significant IOP reduction out to 8 years
- Tableau comparatif des pays : les caractéristiques à connaître avant de se développer à l’international
- Smart exosomes from an Australian technology leader
- Bucharest Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Transmetrics AI is Applied by DB Schenker to Improve Land Transport Network in Bulgaria
- Digi Communications N.V.: Announces repayment of an aggregate amount of approx. EUR 272 million of the Group’s financial debt
- El Liceo Europeo vence el Premio Zayed a la Sustentabilidad 2022 en Europa y Asia Central
- Framework rebrands to daappa, heralding a new phase in fintech solutions designed for private markets
- Digi Communications N.V. Announces the publishing of the Financial Calendar for 2022
- Manufacturing giant Haizol expands their offices in China
- Patients and R&D Leaders Jointly Present at EU Conference on Progress with Patient-Input to Transform Medicine Development
- Seminário Bíblico sobre “O Cumprimento da Palavra de Jesus no Mundo de Hoje”
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- Fidupar Now Live on Framework’s Core Solution
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- Digi Communications N.V. Announces that the offer of the Company’s Romanian subsidiary was designated winner of the auction organised for the allocation of certain radio frecquency entitlements
- New dating site aimed at people with mental health problems launches in Switzerland
- BITSCore Tests Satellite Cyber-Security and Ride-Share Algorithms on Australian Rocket
- StatusMatch.com ed Emirates collaborano per aiutare i frequenti viaggiatori italiani a tornare in volo
- StatusMatch.com and Emirates partner up to help Italian frequent flyers get back in the air
- MinDCet drivers and FTEX powertrain solutions enable EV GaN applications
- Digi Communications NV announces the release of the Q3 2021 Financial Results
- Origami and citoQualis Team up for Startups
- Digi Communications NV announces Investors Call for the Q3 Financial Results presentation
- Digi Communications N.V. announces the extraordinary general meeting’s resolution from 4 November 2021, approving the appointment of KPMG N.V. as the Company’s statutory auditor for the 2021 financial year
- Digi Communications N.V. announces The solution reached by the Bucharest Court of Appeal regarding the investigation conducted by the Romanian National Anticorruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V. Announces the results of the auction organised by the Portuguese Authority for Telecommunications
- Haizol expands its capabilities to include component assembly and product development
- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
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- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
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- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
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- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
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- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
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- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
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- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
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- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
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- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
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- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
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- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP