Roche, Glaxo Seek Nod for IV Osteoporosis Drug

Roche Holding AG and GlaxoSmithKline said on Wednesday they asked U.S. regulators to approve an intravenous form of their osteoporosis drug that could be administered far less frequently.

The drug called Boniva is already approved in a pill form that must be taken once a day. The European drug makers are now seeking permission to sell an intravenous Boniva that would only need to be given once every three months to treat post-menopausal women with the bone-wasting disease. Boniva belongs to a class of frequently prescribed osteoporosis medicines called bisphosphonates. “Boniva Injection may offer a new option for patients who experience gastrointestinal side effects with oral bisphosphonates, or are unable to comply with oral bisphosphonate dosing guidelines,” Roche medical director Keith Friend said in a statement. Bisphosphonates, such as Merck & Co.’s Fosamax and Procter & Gamble’s Actonel, currently are available only in once-daily or once-weekly oral formulations. Earlier this year, Roche and Glaxo filed an application with the Food and Drug Administration for a once-monthly oral Boniva. (Source: Reuters Health, December 2004)