In the areas of oncology and cardiology
Dr. Reddy’s Laboratories has entered into a collaboration with biotechnology company Amgen to market and distribute three Amgen medicines in India in the areas of oncology and cardiology.
Under the terms of the agreement, Dr. Reddy’s will perform a range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), Blincyto (blinatumomab) and Repatha (evolocumab) in India.
Kyprolis was approved by the US Food and Drug Administration in July, in combination with lenalidomide and dexamethasone, for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. It is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Blincyto is the first approved bispecific CD19-directed CD3 T-cell engager. It engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukaemia cells. It was approved by the FDA in 2014, to treat patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
Last month the European Commission (EC) granted marketing authorisation for Repatha, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol despite taking maximum doses of statins or who cannot take statins, who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.