Boniva ibandronate: Phase III data

The double-blind, Japanese Phase III MOVEST trial in about 400 osteoporosis patients ages >55 showed that 100 mg oral Boniva was non-inferior to IV Bonviva ibandronate on the primary endpoint of the change from baseline to 12 months in lumbar spine BMD (5.22% vs. 5.34%). Data were presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases in Milan. In February, Chugai, which is majority owned by Roche, submitted an NDA in Japan for a monthly oral formulation of Boniva to treat osteoporosis. Japan approved a monthly IV formulation of the product in 2013. Chugai partnered with Taisho in 2006 to co-develop and co-market the product in Japan (see BioCentury, Sept. 18, 2006). ...