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.