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news.The Swiss authorities have approved Roche and GlaxoSmithKline's Bonviva for the treatment of postmenopausal osteoporosis, providing the foundations for approval in other countries.
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Bonviva (ibandronic acid), known as Boniva in the US, is the first and only once-monthly tablet for the treatment of postmenopausal osteoporosis.
The Swiss acceptance marks the first approval of Bonviva outside the US, where the product has received approval but has yet to be marketed. The companies were reportedly exploring different methods of dosage to improve convenience for users and are now seeking approval for an intravenous form of the drug in the US.
The treatment received a positive opinion from the EMEA’s Committee for Medicinal Products for Human Use (CHMP) last June and it is expected that European Union marketing authorization will follow later this year.
Bonviva, a potent and highly effective bisphosphonate, 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, compared to the 52 required with current weekly bisphosphonate treatments. This is particularly important as, according to Roche, almost two-thirds of patients on current treatment stop taking their medication within a year, foregoing the bone-building benefits these drugs can provide over time.
The bisphosphonate market has multi-billion-dollar potential with analysts predicting sales of Bonviva to reach $783 million by 2009. If anything, analysts believe this figure may be an underestimation of the drug’s capabilities as it has not taken into account the huge marketing abilities of GlaxoSmithKline, which co-promotes the drug with Roche in both the US and Europe.