Amgen and Onyx’s MAA for Kyprolis is accepted by EMA

The European Medicines Agency has accepted the Marketing Authorization Application (MAA) for Kyprolis (carfilzomib) from US biotech company Amgen (Nasdaq: AMGN) and its subsidiary Onyx Pharmaceuticals for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. The MAA has been granted accelerated assessment by the EMA. It includes data from the Phase III ASPIRE trial as well as other relevant data.

Pablo Cagnoni, president, Onyx Pharmaceuticals, said: “Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing. We look forward to working with European regulators to potentially make this important medication available.”