Amgen Submits Kyprolis for US, EU ReviewBy
Amgen and its subsidiary Onyx Pharmaceuticals, Inc., have submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Kyprolis (carfilzomib) for injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. In the US, the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union (EU), Kyprolis received orphan drug designation, and the MAA has been granted accelerated assessment.
In July, 2012, the FDA granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. In the EU, orphan designation is granted by the EMA for medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000. The intended medicine must aim to provide significant benefit to those affected by the condition.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is in a class of drugs called proteasome inhibitors and was granted accelerated approval by the FDA in 2012. Kyprolis is also approved for use in Argentina, Israel and Mexico.