French approval for Eprex for symptomatic anemia

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 anemia (hemoglobin 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).

Eprex, from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen, is already marketed for various cancer indications and in 2016 generated sales of $1.1 billion. The drug is sold in the USA by Amgen under the Procrit and Epogen trade names

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 authorization 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.