FDA approves Roche and GSK's IV Boniva

Swiss drug major Roche and UK pharmaceutical giant GlaxoSmithKline say that the US Food and Drug Administration has approved their co-developed drug Boniva (ibandronate sodium) injection, making it the first intravenous medication for the treatment of postmenopausal osteoporosis.

The agent, which is the first quarterly regimen medication for the treatment of postmenopausal osteoporosis, is a member of the bisphosphonate class, the most frequently prescribed medicine for osteoporosis.

According to the firms, Boniva administered as a 15-30 second IV injection will provide an alternative for patients who have difficulty with oral dosing requirements, including an inability to sit upright for 30 to 60 minutes and/or swallow a pill. Last year, the FDA approved once-monthly Boniva as the first once-monthly tablet for postmenopausal osteoporosis (Marketletter April 4, 2005).