Japanese launches of subcutaneous injection forms of Pralia and Enbrel, and of Acofide

Among a bunch of Japanese drug launches in the past couple of days, Daiichi Sankyo (TYO: 4568) announced the debut of the osteoporosis treatment Pralia (denosumab, genetic recombinant) subcutaneous injection 60mg syringe, which was approved in Japan for manufacture and marketing on March 25, 2013, and placed on National Health Insurance drug price list, May 24.

Pralia is a fully human monoclonal antibody that specifically inhibits RANKL receptor activator for nuclear factor-k B ligand), an essential mediator for bone resorption. It is a subcutaneous injection for use once every six months as a novel treatment for osteoporosis. In a clinical study on osteoporosis patients in Japan, PRALIA® showed efficacy in reducing risk of vertebral fracture. Daiichi Sankyo has been working on denosumab since 2007, when it licensed the rights from Amgen to develop and market this antibody in Japan. The drug is marketed as Prolia in USA.

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