Takeda's Steovess accepted for national approvals in EU

Japan’s largest drugmaker Takeda Pharmaceuticals (TYO: 4502) says that the European decentralized procedure (DCP) was positively concluded for Steovess (formerly known as EX101), a once-a-week 70mg buffered effervescent alendronate for the treatment of post-menopausal osteoporosis.

The company submitted its application for marketing authorization in multiple countries through the DCP on September 17, 2010, with the UK serving as its Reference Member State. Following its evaluation, the RMS and all concerned European Union member states reached consensus that Steovess is approvable. The regulatory process will enter now into the national phase in which each of the member states shall adopt a national decision and grant national marketing authorizations. Pending those decisions, Takeda anticipates first launches in the second half of 2012. European approval will be used as the basis for submissions in key emerging markets.

Trevor Smith, head of Europe and Canada at Takeda, said: "Osteoporosis affects more than 200 million people globally and its prevalence is expected to increase rapidly as the global population ages. Steovess represents an important new treatment option for these patients, who often stop taking their medications because of the inconvenience associated with existing tablet forms of alendronate. Steovess complements our existing osteoporosis offering and we believe it will be an important new treatment for patients with this debilitating disease in Europe and other key markets."