Janssen-Cilag International NV 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 3, 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).1 EPOANE 3021 March 2017 PHEM/EPR/0317/00011 data were presented at the 21st Annual Congress of the European Hematology Association (EHA) in 2016. Janssen have data exclusivity for one year.