The European Union marketing authorisation has been granted for Bonviva 150mg for the treatment of postmenopausal osteoporosis. Bonviva (ibandronic acid) is the first and only once-monthly tablet for the treatment of postmenopausal osteoporosis. This follows FDA and Swissmedic approval earlier this year, Roche and GlaxoSmithKline (GSK) announced here.
According to a GSK release, Bonviva, a potent and highly effective bisphosphonate1 is the first-ever oral treatment administered as one tablet once a month for any disease. This means patients will only have to take 12 Bonviva tablets a year versus 52 or 365 required with current weekly or daily bisphosphonate treatments.
William M. Burns, CEO Division Roche Pharma said, “We can now offer women with postmenopausal osteoporosis an effective and more convenient regimen which could help them stay on therapy, therefore providing the bone-building benefits they need over time.”
European Union marketing authorisation for once monthly oral Bonviva is based on 2-year results of the MOBILE (Monthly Oral iBandronate In LadiEs) phase III study in 1,609 women with postmenopausal osteoporosis. The study shows the monthly dose was highly effective and well tolerated over two years and is actually statistically superior at increasing bone mineral density (BMD) compared to the daily dose.
In December 2001, Hoffman-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan.