Bonviva injection set for EU approval

Swiss major Roche and UK-based giant GlaxoSmithKline say that a new four-times a year intravenous injection of the osteoperosis medication Bonviva (ibandronic acid), has received a positive recommendation for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use.

The drug is currently available as a once-monthly tablet for the treatment of postmenopausal osteoperosis in more than 38 countries (Marketletters passim). The firms added that, despite the product's efficacy and tolerability, oral bisphosphonates are not suitable for all osteoperosis patients, such as those unable to remain upright and refrain from eating, a requirement of all oral bisphosphonate treatment regimen, or those patients taking several courses of medication concurrently. Peter Matton, Roche's global head for Bonviva, said that, if approved, the new quarterly injection would benefit the difficult-to-treat patient groups.

The Committee's opinion is based on data from the two year Dosing IntraVeneous Administration study (DIVA) which is an ongoing, randomized, double-blind, multicenter study that has enrolled 1,300 women. The results, which were presented to the American College of Rheumatology meeting in November, showed that patients receiving the drug every three months saw a 6.3% improvement in bone-mineral density versus 4.8% for the daily-dosage.