Bonviva (ibandronic acid), the first and only once-monthly tablet for the effective treatment of postmenopausal osteoporosis, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Roche and GlaxoSmithKline (GSK) jointly announced here.
According to a GSK release, with once-monthly Bonviva, a potent and highly effective bisphosphonate, patients will only have to take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments. This is particularly important as almost two-thirds of patients stop taking their osteoporosis treatment within a year, foregoing the bone building benefits these drugs can provide over time. Data show that less frequent dosing has a positive impact on how long a patient continues to take a medication. On approval, Bonviva will be the first ever oral treatment administered as one tablet once a month for any disease.
William M Burns, CEO, Division Roche Pharmaceuticals said, "Bonviva was developed in response to a clear patient need. When approved in Europe, once-monthly Bonviva will offer an effective and more convenient regimen which could help women to stay on therapy and get the bone protection they need."
The CHMP positive opinion was based on the results from MOBILE (Monthly Oral iBandronate In LadiEs), a randomised, double-blind, multinational, non-inferiority trial in 1,609 women with postmenopausal osteoporosis. The MOBILE study showed that the monthly dose was at least as effective as the daily dose. In addition, the monthly dose resulted in even larger increases in Bone Mineral Density (BMD), at lumbar spine and all hip sites, when compared with the daily dose, and was statistically superior to the daily dose at all these sites after two years.
Bonviva (known in the US as Boniva) was approved by the US Food and Drug Administration in March 2005. In the US, Boniva 150mg is indicated for the treatment of osteoporosis in postmenopausal women.