Roche and GlaxoSmithKline have submitted a new drug application (NDA) with the US FDA for a novel, intermittent intravenous (IV) injection formulation of bisphosphonate Boniva (ibandronate sodium) for the treatment of postmenopausal osteoporosis. Bisphosphonates, the most frequently prescribed medicines for treating osteoporosis, currently are available only in once-daily or once-weekly oral dosing formulations, the companies announced here.
The FDA submission of Boniva IV includes the first year results of the landmark study DIVA (Dosing Intra Venous Administration) study, released earlier this year. The study compared two IV treatment regimes (one injection every 2 months and one injection every quarter) with a daily oral regime (which had shown in a previous pivotal study very good vertebral fracture reduction data).
William M. Burns, head of Roche's Pharmaceutical Division said: "Boniva IV brings a new choice to treatment and is expected to be the first bisphosphonate treatment for all patients who for various reasons are unable to tolerate oral bisphosphonates. This submission comes as an addition to the unique once monthly oral presentation currently under review with the FDA. With Boniva we plan to introduce two totally unique intermittent treatments which we expect will meet a clear need to improve adherence to bisphosphonate therapy."
On average, patients receiving quarterly or bi-monthly intravenous injections have a significantly larger increase in their bone mass (as measured by bone mineral density), compared with those receiving daily oral medication (5.1% and 4.8% versus 3.8%). Likewise more patients responded to injectable Boniva (92.6% and 92.1%) than to the daily tablets (84.9%) as measured by bone mass increases and also bone marker tests in the blood, release from Roche said.
Boniva has been developed both as an intravenous injection and as a once-monthly oral formulation.