Roche and GlaxoSmithKline have received the green light of approval in Switzerland for a once-monthly, oral version of their osteoporosis therapy Bonviva 150mg (ibandronic acid), setting the stage for pan-European approval.
Bonviva is the first and only once-monthly tablet for the treatment of postmenopausal osteoporosis, and this is the first approval of the drug outside the USA, where it is known as Boniva [[29/03/05a]]. Full European Union marketing authorization is expected to follow later on this year, after a thumbs up from the region’s scientific advisory board in June [[27/06/05b]], [[20/09/04c]].
Bonviva is a member of the bisphosphonate class, and is the first-ever oral treatment administered as one tablet once a month for any disease, say Roche and GSK. This, they add, is particularly important as almost two-thirds of patients on current treatment stop taking their osteoporosis treatment within a year.
The Swiss approval was based on the one-year results of the MOBILE Phase III study in 1,609 women with postmenopausal osteoporosis, which showed that the monthly dose was at least as effective as the daily dose in building bone mineral. In addition, the monthly dose resulted in even larger increases in bone mineral density 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 is the only bisphoshonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.
Roche and GSK will be keeping their fingers crossed that Bonviva makes a significant dent in a marketplace currently dominated by Merck & Co’s $3.2 billion-dollar-a-year market leader, Fosamax (alendronate), because of its ease of dosing.