UK-based GlaxoSmithKline (GSK) and Swiss pharmaceutical company Roche have been granted European marketing authorization for the quarterly intravenous (IV) injection of the osteoporosis medication Bonviva (ibandronic acid). The medication is the first injection in its class for the treatment of osteoporosis in postmenopausal women to be approved in the EU. The U.S. FDA approved the treatment earlier in the year.
"We are delighted that [the] injection has received EU approval," said Roche CEO William Burns. "Physicians throughout Europe will now be able to treat more women with a bisphosphonate, taking advantage of the proven bone strengthening benefits of this therapeutic class."
Bonviva is already approved as a well-tolerated once-monthly oral tablet in more than 38 countries. The IV formulation of the drug, noted GSK and Roche, will enable women who are unable to take bisphosphonate orally -- due, for instance, to problems with standing upright or swallowing -- to receive the medication.