EU approves Roche/GSK's Bonviva IV

Swiss drug major Roche and UK-based GlaxoSmithKline, the world's third-largest drugmaker, have received European marketing authorization for their quarterly intravenous injectible osteoporosis medication, Bonviva (ibandronic acid).

The product is the first ever injection in its class for the treatment of osteoporosis in postmenopausal women to be approved in the European Union, which swiftly follows its clearance by the US Food and Drug Administration earlier this year.

The drug is already approved as a once-monthly oral tablet in over 38 countries worldwide and oral bisphosphonates of its kind are the most commonly-prescribed treatment for postmenopausal osteoporosis. However, the companies point out that a minority of women may not be able to take their bisphosphonate orally, as they may be unable to stay upright for the required length of time, or have swallowing problems. It adds that, for these women, Bonviva injection is well-positioned to satisfy their needs.