Swiss drug major Roche and UK pharmaceutical giant GlaxoSmithKline have obtained approval to market Bonviva (ibandronic acid) 150mg, the first and only once-monthly tablet for the treatment for postmenopausal osteoporosis, in the European Union, hot on the heels of Swissmedic’s green light earlier this month [[09/09/05e]].
The agent, a biphosphonate, represents the first ever oral therapy to be administered once a month for any chronic disease, so patients will need to take just 12 tablets a year compared with the 52 or 365 required with traditional weekly or daily bisphosphonate treatments. This has massive implications for treatment compliance, say Roche and GSK, as up to two-thirds of osteoporosis sufferers cease treatment within a year, and therefore fail to benefit from the bone-building benefits that can only be achieved over time.
Marketing clearance was based on one-year results of the MOBILE Phase III study, which involved 1,609 women with postmenopausal osteoporosis and showed that the monthly dose was at least as effective as the daily dose in building bone mineral. Furthermore, the monthly dose resulted in even larger increases in bone mineral density at lumbar spine and all hip sites than the daily dose. Bonviva is the only bisphoshonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.
Commenting on the approval, William Burns, Chief Executive of Roche’s Pharma division, stated: “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.” Bonviva’s simple dosing regimen should provide it with a significant advantage over the current market leader, US drug major Merck & Co’s $3.2 billion-dollar-a-year Fosamax (alendronate).