UK drug giant, GlaxoSmithKline, and Swiss partner, Roche, were celebrating on Friday after the US Food and Drug Administration gave the green light to a once-monthly version of their postmenopausal osteoporosis agent, Boniva/Bonviva (ibandronate).
The firms say that Boniva is the first-ever oral treatment administered as one tablet once a month for any chronic disease, and expect to the product will be available in US pharmacies in April. The FDA originally approved a once-daily version of the drug back in 2003, but a once-monthly version will clearly give the drug an added advantage over established compounds in the burgeoning osteoporosis market, such as Merck & Co’s $3.2 billion-dollar-a-year market leader, Fosamax (alendronate).
The product is undergoing regulatory review in markets across the world, including Europe where it will be marketed under the trademark, Bonviva [[20/09/04c]]. In December, Roche and GSK filed an application with the FDA to market an intravenous formulation of the compound [[09/12/04h]].