(COMMUNIQUÉ DE PRESSE) LONDRES, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON : GSK), une multinationale scientifique britannique , a annoncé la troisième étape réglementaire majeure pour son daprodustat, un inhibiteur oral du facteur prolyl hydroxylase inductible par l’hypoxie (HIF-PHI), pour le traitement potentiel des patients atteints d’anémie liée à l’insuffisance rénale chronique (IRC). La Food and Drug Administration (FDA) des États-Unis vient d’accepter la demande de nouveau médicament (NDA) pour le médicament oral daprodustat suite à l’acceptation de la soumission réglementaire de l’Agence européenne des médicaments (EMA) et à l’approbation de Duvroq (daprodustat) au Japon.
La NDA du daprodustat est basée sur les résultats positifs du programme d’essais cliniques de phase III ASCEND, qui comprenait cinq essais pivots évaluant l’efficacité et l’innocuité du daprodustat pour le traitement de l’anémie dans tout le spectre de l’IRC. Les résultats des principaux essais sur les résultats cardiovasculaires ont été publiés dans le New England Journal of Medicine en novembre 2021 et incluaient la non-dialyse (ASCEND-ND) et dialyse (ASCEND-D) Patients atteints d’IRC. Ces essais ont démontré que le daprodustat améliorait et/ou maintenait l’hémoglobine (Hb) dans le niveau cible (10-11,5 g/dL) sans augmentation des événements cardiovasculaires indésirables majeurs (MACE) dans les populations en intention de traiter (ITT) dans chaque étude pivot , par rapport à la norme de soins, un agent stimulant l’érythropoïétine (ASE), dans les milieux de patients non dialysés et dialysés.
Daprodustat est actuellement approuvé au Japon sous le nom de Duvroq pour les patients souffrant d’anémie rénale. In mars 2022, l’Agence européenne des médicaments (EMA) a validé la demande d’autorisation de mise sur le marché (AMM) pour le daprodustat, actuellement en cours d’examen. Les dépôts réglementaires supplémentaires devraient se poursuivre tout au long de 2022.
À propos du programme d’essais cliniques de phase III ASCEND
Le programme ASCEND comprend cinq essais de phase III visant à évaluer l’efficacité et le profil d’innocuité du daprodustat pour le traitement de l’anémie de l’IRC tout au long du parcours de la maladie. Le programme a inscrit plus de 8 000 patients traités pendant 4,26 ans maximum. Les résultats des cinq essais ont été présentés lors de la Kidney Week 2021 de l’American Society of Nephrology.
Les résultats des deux essais pivots sur les résultats cardiovasculaires, ASCEND-ND et ASCEND-D, portant respectivement sur des patients non dialysés et sur des patients dialysés, ont également été publiés dans le New England Journal of Medicine[i ],[ii] :
- ASCEND-ND (Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) a recruté 3 872 patients non dépendants de la dialyse atteints d’anémie ou d’IRC qui ont soit quitté le traitement standard (ASE) ou ne reçoivent pas actuellement de traitement ASE pour recevoir du daprodustat ou un contrôle ASE (darbepoetin alfa). Des protocoles de gestion du fer ont été institués dans les deux bras de l’essai. L’essai a atteint ses principaux critères d’efficacité et d’innocuité. Les résultats ont montré que le daprodustat améliorait et/ou maintenait l’Hb dans le niveau cible (10-11,5 g/dL) pour ces patients, et l’analyse primaire de sécurité de la population ITT a montré que le daprodustat a atteint la non-infériorité de MACE par rapport au contrôle ESA.< /li>
- ASCEND-D (Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) a recruté 2 964 patients dialysés souffrant d’anémie ou d’IRC qui ont été transférés pour recevoir du daprodustat ou un contrôle ESA à partir d’un traitement ESA standard. Un protocole uniforme de gestion du fer a été institué dans les deux volets de l’essai. L’essai a atteint ses principaux critères d’efficacité et d’innocuité. Les résultats ont montré que le daprodustat améliorait ou maintenait l’Hb dans les niveaux cibles (10-11,5 g/dL) pour ces patients, et l’analyse de sécurité primaire de la population ITT a montré que le daprodustat atteignait la non-infériorité de MACE par rapport au contrôle ESA.
À propos de l’anémie des maladies rénales chroniques
L’IRC, caractérisée par une perte progressive de la fonction rénale, est un fardeau mondial croissant pour la santé publique.[iii] Les facteurs de risque d’IRC incluent l’hypertension , le diabète, l’obésité et les troubles rénaux primaires.[iii] En outre, l’IRC est un facteur de risque indépendant de maladie cardiovasculaire.< sup>[iii] L’anémie est une complication importante et fréquente de l’IRC.[iv] Cependant, il est souvent mal diagnostiqué et sous-traité chez les patients atteints d’IRC à un stade précoce, tels que ceux qui ne le sont pas sur la dialyse.[iv] Plus de 700 millions de patients souffrent d’IRC dans le monde, et on estime qu’un patient sur sept souffre d’anémie.[v],[vi]&nb sp ;Lorsqu’elle n’est pas traitée ou sous-traitée, l’anémie de l’IRC est associée à de mauvais résultats cliniques et entraîne un fardeau considérable pour les patients et les systèmes de santé.[iv]
À propos de daprodustat
Daprodustat, un HIF-PHI, appartient à une nouvelle classe de médicaments oraux indiqués pour le traitement potentiel de l’anémie de l’IRC chez les patients adultes non dialysés et sous dialyse. L’inhibition des enzymes prolyl hydroxylase sensibles à l’oxygène stabilise les facteurs inductibles par l’hypoxie, ce qui peut conduire à la transcription de l’érythropoïétine et d’autres gènes impliqués dans la correction de l’anémie, similaires aux effets physiologiques qui se produisent dans le corps humain à haute altitude. Le daprodustat a été développé pour fournir une option de traitement par voie orale pratique aux patients souffrant d’anémie ou d’IRC.
À propos de GSK
GSK est une entreprise mondiale de soins de santé axée sur la science. Pour plus d’informations, veuillez consulter www.gsk.com/about-us.
Mise en garde concernant les déclarations prospectives
GSK avertit les investisseurs que toutes les déclarations ou projections prospectives faites par GSK, y compris celles faites dans cette annonce, sont soumises à des risques et incertitudes qui peuvent faire en sorte que les résultats réels diffèrent sensiblement de ceux projetés. Ces facteurs comprennent, mais sans s’y limiter, ceux décrits dans le rapport annuel de la société sur formulaire 20-F pour 2021, et tout impact de la pandémie de COVID-19.
[i] Singh A, et al. Daprodustat pour le traitement de l’anémie chez les patients non dialysés. N Engl J Med. 2021 ; 385:2313-2324.
[ii] Singh A, et al. Daprodustat pour le traitement de l’anémie chez les patients sous dialyse. N Engl J Med. 2021;385:2325-2335.
[iii] ; Hill NR, Fatoba ST, Oke JL, et al. Prévalence mondiale de l’insuffisance rénale chronique : une revue systématique et une méta-analyse. PLoS One. 2016;11(7):e0158765.
[iv] St Peter WL, Guo H, Kabadi S, et al. Prévalence, schémas de traitement et utilisation des ressources de soins de santé chez Medicare et les patients atteints d’insuffisance rénale chronique non dépendants de la dialyse avec et sans anémie aux États-Unis. BMC Nephrol. 2018;19(1):67.
[v] Bikbov B, Purcell CA, Levey AS, et al. Fardeau mondial, régional et national de l’insuffisance rénale chronique, 1990-2017 : une analyse systématique pour l’étude sur la charge mondiale de morbidité 2017. Lancet. 2020;395(10225):709-733..
[vi] Stauffer ME, Fan T. Prévalence de l’anémie dans les maladies rénales chroniques aux États-Unis. PLoS One. 2014;9 (1):e84943.
AVIS DE NON-RESPONSABILITÉ: La version française de ce communiqué de presse est une traduction du communiqué de presse original, qui est rédigé en anglais, et est uniquement à des fins d’information. En cas de divergence, la version anglaise de ce communiqué de presse prévaudra.
Contact presse:
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SOURCE: GlaxoSmithKline plc
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- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- 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
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- 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
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- 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
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- 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
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- 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
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- 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
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- 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