Japan-based Amgen Astellas BioPharma and Astellas Pharma (TYO: 4503) say that their proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab [genetically recombination] Injection) Syringe has become available in the Japanese market.
Repatha was developed in Japan by joint venture Amgen Astellas and US biotech major Amgen (Nasdaq: AMGN) and was approved by the Ministry of Health, Labor and Welfare earlier this year (The Pharma Letter January 23). Amgen Astellas and Astellas will co-promote Repatha in Japan.
Repatha is indicated for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins).
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