FDA approves Roche, GlaxoSmithKline's Boniva, first intravenous treatment for postmenopausal osteoporosis

By E. Janene Geiss

Philadelphia, Jan. 6 - Roche and GlaxoSmithKline said Friday that the U.S. Food and Drug Administration has approved Boniva (ibandronate sodium) injection, the first intravenous medication for the treatment of postmenopausal osteoporosis.

Boniva injection, the first quarterly medication for the treatment of postmenopausal osteoporosis, is a member of the bisphosphonate class, which is the most frequently prescribed medicine for osteoporosis. It is administered by a health care professional once every three months, according to a company news release.

"Boniva injection is a truly novel osteoporosis therapy. It represents an important new opportunity to bring the bone-strengthening benefits of Boniva to more women, including those who have difficulty with dosing requirements of oral bisphosphonates," Robert R. Recker, director of Creighton University Osteoporosis Research Center in Omaha, Neb., and an investigator in Boniva clinical trials, said in the release.

Boniva will provide an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including an inability to sit upright for 30 to 60 minutes or swallow a pill, officials said.

And because Boniva injection will be administered by health care professionals, clinicians will have a greater awareness of patient compliance with therapy, officials said.

Boniva was approved by the FDA based on results of a clinical trial in 1,358 women with postmenopausal osteoporosis.

Boniva will be available early this year, officials said.

The FDA approved once-monthly Boniva in March 2005 as the first once-a-month tablet for postmenopausal osteoporosis. The once-monthly tablet (150 mg) became available in April 2005, officials said.

Approval of the injection and tablet follow a Surgeon General's Report that elevated osteoporosis to a major public health threat on par with smoking and obesity, officials said.

Forty-four million Americans over 50 years of age are affected by or at risk for osteoporosis, a disease that causes bones to become weak and more likely to break and can result in severe pain, deformity, disability, hospitalization and even death, according to the release.

In December 2001, Roche and GlaxoSmithKline announced their plans to co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan.

Roche is a Nutley, N.J., research-driven pharmaceutical, diagnostics and health care products company.

GlaxoSmithKline is a Research Triangle Park, N.C., research-based pharmaceutical and health care company.

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