Roche and GlaxoSmithKline plc announced 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.
The application is supported by clinical trial data (the MOBILE study), which investigated more convenient oral regimens of Bonviva for the treatment of osteoporosis. Both Bonviva doses studied (100 mg and 150 mg monthly) were at least as effective as the daily regimen in increasing spine Bone Mineral Density (BMD), a commonly used marker of drug efficacy. Preliminary safety evaluation indicates that the monthly oral regimens were well tolerated, a release from Roche said.
"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," he added.
"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 US FDA in May 2004, the release added.
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.
In December 2001, Roche and GSK had announced they would co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in all countries, except Japan.