Eprex marketing authorisation extended to include treatment of symptomatic anaemia
French Health Authority ANSM grants approval in the Mutual Recognition Procedure; the relevant health authorities are required to implement the new indication within 30 days.
Janssen-Cilag has announced the French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has approved Eprex (epoetin alfa) for the treatment of symptomatic anaemia (haemoglobin concentration of ≤10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL).
The ANSM acted as the reference Member State within the Mutual Recognition Procedure (MRP), which has now concluded and resulted in an extension to the marketing authorisation for Eprex. Upon the conclusion of the extension procedure within the MRP the other European health authorities are required to implement the new indication into their national Summary of Product Characteristics (SmPC) and package leaflet within 30 days.
This approval was based on results from the international Phase III, randomised, double-blind, placebo-controlled, multicentre study, EPOANE 3021 along with three registry studies from across Europe. EPOANE 3021 demonstrated the efficacy and safety of Eprex as a treatment for anaemia, in adult patients with low or intermediate-1-risk MDS, as classified by an International Prognostic Scoring System (IPSS). EPOANE 3021 data were presented at the 21st Annual Congress of the European Hematology Association (EHA) in 2016. Janssen have data exclusivity for one year.
“This announcement is extremely welcome, as there have been no erythropoiesis stimulating agents approved to treat anaemia in patients with MDS until now, despite the fact that it contributes significantly to their symptoms,” said Pierre Fenaux, principal investigator of EPOANE 3021, and Professor of Hematology, Hôpital St Louis/Université, Paris, France.
“We are pleased with the outcome of the MRP which brings us one step closer to offering a new treatment option to patients with MDS-related anaemia throughout Europe. This approval is a testament to our long-standing commitment to patients living with cancer,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, the Middle East and Africa.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance