
Lundbeck welcomes acceptance of Vyepti’s marketing authorization application by the European Medicines Agency for the prevention of migraine
(PRESS RELEASE) VALBY, Denmark, 22-Dec-2020 — /EuropaWire/ — Danish international pharmaceutical company, H. Lundbeck A/S (Lundbeck) announces that its marketing authorization application for Vyepti™ (eptinezumab-jjmr) has been accepted by the European Medicines Agency (EMA). The filing seeks approval to introduce Vyepti as preventative therapy for migraine to European citizens.
Vyepti is the most recent strategic brand added to Lundbeck’s portfolio of treatments. As a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), Vyepti prevents CGRP from binding to its receptor, and thereby prevents migraine attacks. Vyepti is set to be the first migraine preventive antibody that is given by intravenous (IV) administration which may provide benefits such as attaining immediate therapeutic drug levels in the blood stream and efficacy as early as on the day of infusion. As a 30-minute IV infusion administered every 12 weeks, Vyepti offers patients with migraine a preventive therapy with 4 treatments per year.
The acceptance of the Vyepti MAA for review marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Vyepti was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults 22 February 2020 and was launched in April on the U.S. market. During 2020, Lundbeck has submitted an application for market authorization of Vyepti in several countries, including Canada, Australia, Switzerland, United Arab Emirates, Kuwait, the Philippines, Singapore, Indonesia, and Brazil. Development activities in other regions and countries around the world, including China and Japan, are in planning.
Dr. Johan Luthman, Executive Vice President, R&D at Lundbeck said:
“Lundbeck is pleased with the acceptance of Vyepti for regulatory review. Vyepti will address the need for powerful migraine prevention with an early onset of effect. There are many patients who are impacted by migraine and they deserve innovative and better treatment options – including migraine prevention that works in an effective, rapid, and sustained way. Therefore, we look forward to work closely with European health authorities to make Vyepti available as soon as possible.”
About VYEPTI™
Vyepti is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine1 and PROMISE-2 in chronic migraine2), where Vyepti met its primary endpoint of decrease in mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion. The safety of Vyepti was evaluated in 2,076 adult patients with migraine who received at least one dose of Vyepti. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment due to adverse reactions.
About Migraine
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.3 Not only is headache painful, but migraine also impose both a social and financial burden, affecting close to 50 million people in Europe4. Repeated headache attacks, and often the constant fear of the next one, damage family life, social life and work life. Furthermore, frequent use of acute migraine treatments may leave patients experiencing, or at risk of developing, medication overuse headache.
In Europe, migraine alone costs the economy EUR 18 billion annually according to the Cost of Brain Disorders in Europe paper4 and this is without the indirect cost associated with presenteeism (i.e. productivity losses due to reduced efficiency of persons who are not sufficiently ill to be absent from work). It is the second leading cause of years lived with disability (YLD) among all diseases and it is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study.5 Migraine has a profound impact on patients’ lives, their relationships, as well as their ability to carry out activities of daily living.
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).
References
1. Ashina M, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254
2. Lipton RB, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377
3. Villalón CM. The role of CGRP in the pathophysiology of migraine and efficacy of CGRP receptor antagonists as acute antimigraine drugs. Pharmacol Ther. 2009;124(3):309-323
4. Gustavsson A, et al. Cost of disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Oct;21(10):718-79.
5. Steiner TJ, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19(1):17.
Media contacts:
Juliane Lenzner
Vice President, Corporate Communication
JULZ@lundbeck.com
+45 36 43 40 00
Investors:
Palle Holm Olesen
Vice President, Investor Relations
PALO@lundbeck.com
+45 30 83 24 26
SOURCE: H. Lundbeck A/S
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- ASI President John Cross Named AGMA Chairman
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 31 May 2019
- Breakthrough on laser powder bed fusion technology brings effective production of larger componentscloser to mainstream
- PDA Announces All-Star Speaker Lineup for Advanced Therapy Medicinal Products Conference
- Digi Communications N.V.: Exercise of stock options by the Executive Directors of the Company
- Digi Communications N.V. announces DIGI Kft., the Hungarian subsidiary of the Company, launches mobile telephony services in Hungary
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 21 and 24 May 2019
- ZYXEL READY WITH 5G SAMPLES IN AUGUST 2019
- Digi Communications N.V. announces the initiation of the share buy-back program as authorized by the Company’s GSM on 30 April 2019
- Digi Communications N.V Q1 2019 Financial Report and the report regarding legal documents for April 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 released
- Digi Communications N.V. announces the new date of the Conference Call for the presentation of the Q1 2019 Financial Report. Update to the Company’s 2019 Financial Calendar.
- Rhenium-SCT® (SCT= Skin Cancer Therapy) now being offered in Hanau, Germany
- Project consortium aims at driving the adoption of selective laser melting (SLM) for large scale metal parts printing
- Digi Communications N.V. announces the availability of the instructions on the 2018 share dividend payment
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 29 April 2019 – 1 May 2019, under the class B shares buy-back progr
- Biodiversity Report Is Urgent Call to Action Beyond Fixes; Geneva Global Initiative Calls on World Community to Focus on Concrete Actions
- Digi Communications N.V.’s general Shareholders’ meeting resolutions from 30 Apr 2019 approving, amongst others, the 2018 Annual Accounts and the availability of the adopted Annual Financial Report for the year ended Dec 31, 2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions occurred under DIGI symbol, 22 – 26 April 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 15 April 2019 – 19 April 2019s
- XPAND Code was successfully scanned from 200 meters/700 feet at Olympics stadium
- Wasser eingießen, Warten und Einschalten
- Digi Communications N.V.: Reporting of legal documents concluded by the company in March 2019 in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 published
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 8 and 12 April 2019
- Snowman releases new EP
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 1 – 5 April 2019
- Streamlining adoption of high-speed and high-resolution surface texturing delivered with the Prometheus project
- Customer Data Platform Institute Launches RealCDP to Reduce CDP Confusion
- ASI Technologies Focuses on the future as ASI Drives, and New AGV Pallet Robot, FRED2500
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 25 March 2019 – 29 March 2019
- Towards a Europe of Stakeholder Nations
- Associazione Veneta Lotta alla Talassemia (AVLT) and the UK Thalassaemia Society (UKTS) Clarification on European Regulatory Status of LENTIGLOBIN™
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 19 March 2019 – 22 March 2019
- A new flagship project on Additive Manufacturing skills aims to maintain Europe leading position in industrial competitiveness
- Jeroen Schouten Named Regional Manager, Europe of AeroGo, Inc.
- Digi Communications N.V. Convocation of the Company’s general shareholders meeting for 30 April 2019 for the approval of, among others, the 2018 Annual Report and of the 2018 Financial Statements
- España arrasa con la competencia y es nombrado como el país ideal para estudiar en el extranjero
- Xverify targets European Email Verification market with local data processing, Dublin office
- Digi Communications N.V. announces the resignation by Mr. Sambor Ryszka from his position as non-executive director of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 11 and 15 March 2019
- Digi Communications N.V.: Reporting of legal documents concluded by the company in February 2019 in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 published
- Admission of Digi Communications N.V. €200,000,000 5.0% additional senior secured notes due 2023 to the listing on the Official List and trading on Irish Stock Exchange’s Main Securities Market
- Digi Communications N.V. announces the appointment of Dan Ioniță as a non-executive director of RCS & RDS S.A., the Romanian subsidiary of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 4 and 8 March 2019
- Digi Communications N.V. announces share transaction made by an executive director of the Company with class B shares on 4 march 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 25 February – 1 March 2019
- Digi Communications N.V. announces share transaction made by an executive director of the Company with class B shares on 1 march 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 18 and 22 February 2019
- Digi Communications N.V.: finalization and registration by the Company of the conversion of 1,200,000 A shares into an equal number of class B shares
- Digi Communications N.V.: Exercise of stock options by a PDMR in accordance with the stock option plan for the Group’s Romanian employees
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 11 and 15 February 2019
- Report of legal documents concluded by DIGI Communications N.V. in January 2019 or in other period but effective in January 2019
- Digi Communications N.V. announces Availability of Preliminary Financial Report for the year ended December 31, 2018 for Digi Communications N.V. Group
- Mono Solutions launches a new interface to drive the ultimate do-it-with-me (DIWM) experience
- Digi Communications NV Announces Investor Call on the Preliminary Financial Results for the year ended 31 December 2018
- Digi Communications NV: New date of the Conference Call for the 2018 Preliminary financial results; Update to the 2019 Company’s Financial Calendar
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 4 and 8 February 2019
- R.W. Chelsea Holdings Ltd Starts To Hold Fixed Income Investor Meetings In Vienna, Zurich, Geneva and London
- Digi Communications N.V. successfully increased and priced its Offering at €200,000,000 5.0% additional senior secured notes due 2023
- Digi Communications N.V. to offer additional €125,000,000 5.0% senior secured notes due 2023; new notes will be consolidated and treated as its existing €350,000,000; adjustment on interim unaudited consolidated financial statements for the nine-month period ending September 30, 2018
- World's largest superhero statue to be built in Central Europe
- The resignation of Mr. Bendei Ioan – VP and executive director of RCS&RDS S.A., DIGI COMMUNICATIONS N.V.’s subsidiary in Romania
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 28 January 2019 – 1 February 2019
- RCH Group to Showcase Integrated Selling Solutions at EuroCIS
- Mono and bfound partner to expand digital offerings for small businesses in the Middle East
- Digi Communications N.V. publishes the Independent Limited Assurance Report in accordance with Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- ERRATA of the reports dated 15 Jan 2019 and 15 Oct 2018 regarding the legal acts concluded by DIGI Communications N.V. in Dec 2018 and Sep 2018
- REVEALED: Experts reveal the best dates to book your summer holiday in Spain
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 21 – 25 January 2019
- Céline Dion visite son premier concept store de vêtements CELINUNUNU à Paris
- Anytime, anywhere tailored learning opportunities for welding professionals and apprentices alike
- i5invest открива офис в България
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 14 - 18 January 2019
- Mono helps Fonecta strengthen their digital presence offering for SMBs
- The Bucharest Tribunal’s decision regarding the investigation conducted by the Romanian National Anti-corruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V.: Exercise of stock options by a PDMR in accordance with the stock option plan approved by the Company for the Romanian employees of the Group in 2017
- Report of legal acts concluded by DIGI Communications N.V. in accordance with Romanian Law no. 24/2017 and FSA Regulation no. 5/2018 for December 2018
- Digi Communications N.V.: resolution of the Board of Directors to convert class 1,200,000 A shares into an equal number of class B shares for the purpose of the ongoing employees and directors stock option plans
- CELINUNUNU OUVRE SON PREMIER POP-UP À PARIS
- DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 07 – 11 January 2019
- Digi Communications NV: Announcement of the Conference Call for the 2018 Preliminary financial results. Update to the 2019 Company’s Financial Calendar
- A new Government Emergency Ordinance imposing additional corporate taxes with impact on the telecommunications sector in Romania
- DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 31 December 2018-04 January 2019
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