Roche and GlaxoSmithKline (GSK) have received an approval from the US Food and Drug Administration for a new, quarterly intravenous (I.V.) injection of the potent and highly effective osteoporosis drug Boniva (ibandronic acid).
Boniva (known as Bonviva outside the US), is already approved as an effective and well-tolerated once-monthly tablet in 33 countries. However, for some women with postmenopausal osteoporosis, oral bisphosphonates are not suitable. These women may be unable to take oral bisphosphonate therapy due to another medical condition or because they can not stay upright for the required length of time. For these women, Boniva injection offers a way to gain the proven bone strengthening benefits of bisphosphonate therapy, claims a Roche release.
William M. Burns, CEO Division Roche Pharma said, "The US approval of quarterly Boniva injection represents an important new opportunity to bring the bone-strengthening benefits of bisphosphonate therapy to more women. Boniva will now be available as two innovative treatment options that may help patients to stay on therapy."
Gorana Dasic, the US ibandronate medical director at GSK stated, "Boniva injection is the first I.V. bisphosphonate to be approved for osteoporosis treatment anywhere in the world. It was developed in response to the needs of a specific group of patients and supports our vision to bring bisphosphonate treatment options to more postmenopausal women."
Boniva injection is presented as a pre-filled syringe and is administered once every three months by a healthcare professional as a 15-30 second injection.
The release further stated that the FDA approval of Boniva injection was based on one year results from the two year DIVA (Dosing IntraVenous Administration) study. DIVA investigated the efficacy, safety and tolerability of Boniva injection in comparison to the once-daily oral formulation of Boniva and found it to be highly effective and well-tolerated. Previous studies have shown that once-daily oral ibandronate reduced the risk of vertebral fracture in women with postmenopausal osteoporosis by 62% when taken over three years.
DIVA (Dosing IntraVenous Administration) is a multinational, randomised, double-blind, active control multi-centre study in more than 1,300 women with postmenopausal osteoporosis aged between 55 and 80 years of age.
The marketing authorisation application (MAA) for Bonviva injection was submitted to the European Medicines Agency (EMEA) in April 2005.