European positive opinion for first quarterly I.V. injection for postmenopausal osteoporosis

Roche and GlaxoSmithKline (GSK) announce that a new quarterly intravenous (I.V.) injection of the highly-effective osteoporosis medication Bonviva (ibandronic acid) has been recommended for approval in the EU by the Committee for Medicinal Products for Human Use (CHMP). Once approved, this will be the first ever I.V. injection for the treatment of osteoporosis in postmenopausal women available in the EU.

Bonviva is already approved as an effective and well-tolerated (1) once-monthly oral tablet in more than 38 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 cannot stay upright for the required length of time*. For these women, Bonviva Injection offers a way to gain the proven bone strengthening benefits of bisphosphonate therapy.

Peter Matton, Roche's Global Head for Bonviva commented: "We know there is a specific group of women who are unable to take oral bisphosphonates. This new quarterly injection of Bonviva allows them to also benefit from this effective class of osteoporosis treatment."

Pierre Delmas, Professor of Medicine and Rheumatology and Director of the INSERM Research Unit in Lyon, said: "Oral bisphosphonates are the most commonly prescribed treatment for postmenopausal osteoporosis. Furthermore, recent studies have shown women prefer Bonviva once-monthly to once-weekly oral bisphosphonate treatment, finding it more convenient. (2)** However, for those women who cannot take oral medication, a quarterly injection of Bonviva would provide healthcare professionals with an important, alternative treatment option."

Bonviva Injection will be presented as a 3mg/3ml solution in a pre-filled syringe and is administered by a healthcare professional as an intravenous injection over 15 - 30 seconds once every three months.

The CHMP positive opinion was based on results from the 2 year DIVA (Dosing IntraVenous Administration) study. (3) DIVA investigated the efficacy, safety and tolerability of Bonviva Injection in comparison to the once-daily oral formulation of Bonviva and found it to be highly effective and well-tolerated. (3) 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. (4)