Bonviva, to treat osteoporosis, submitted for marketing authorisation in Europe

Sep 20 2004

Roche and GlaxoSmithKline announced today the submission of a Marketing Authorisation Application to the European authorities for a novel, once-monthly oral formulation of their new bisphosphonate, Bonviva (ibandronate), for the treatment of postmenopausal osteoporosis.

"Bonviva is expected to be the first once-monthly tablet for osteoporosis, potentially enhancing compliance for patients throughout Europe. It offers the efficacy of a bisphosphonate with the simple convenience of just 12 tablets a year," commented William M. Burns, Head of Roche Pharmaceuticals Division. “This follows the filing for the once monthly regimen in the US earlier this year and brings us a step closer to commercialising the first ever monthly oral formulation of any pharmaceutical brand.”

The application is supported by clinical trial data (the MOBILE study), which investigated more convenient oral regimens for treatment of postmenopausal osteoporosis. Both doses studied (100 mg and 150 mg monthly) were at least as effective as the 2.5 mg daily regimen in increasing spine Bone Mineral Density (BMD). Preliminary safety evaluation indicates that the monthly oral regimens were well tolerated.

“A dosing regimen of just a single tablet once a month offers patients a new degree of freedom, potentially making it easier for them to take their therapy and stay on it,” observed Andrew Witty, President, Pharma Europe at GSK.

The European Commission approved the once-daily formulation in February 2004, and the companies have been exploring more convenient dosing options before launching the product. A supplemental new drug application (sNDA) for the once-monthly formulation was filed with the U.S. Food and Drug Administration (FDA) in May 2004.

Bonviva, a potent bisphosphonate, has been studied to date in clinical trials involving over 9,000 patients. The ongoing clinical development programme is evaluating monthly oral and bi-monthly/quarterly intravenous dosage regimens in women with postmenopausal osteoporosis. Once daily Bonviva is indicated for the treatment and prevention of osteoporosis in postmenopausal women by reduction of elevated bone turnover, increasing bone mineral density and reduction of the incidence of vertebral fractures.

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