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| | | | New Bonviva® quarterly injection approved in Europe for postmenopausal osteoporosis Apr 2nd 2006
First quarterly injection will bring benefits of bisphosphonate therapy to more women. 
GlaxoSmithKline and Roche announce that European marketing authorisation has been granted for the highly effective quarterly intravenous (I.V.) injection of the osteoporosis medication Bonviva® (ibandronic acid).
Bonviva Injection is the first ever injection in its class for the treatment of osteoporosis in postmenopausal women to be approved in the EU. This European approval swiftly follows the approval in the US by the FDA earlier this year.
William M. Burns, CEO Division Roche Pharma said, ‘We are delighted that Bonviva Injection has received EU approval. Physicians throughout Europe will now be able to treat more women with a bisphosphonate, taking advantage of the proven bone strengthening benefits of this therapeutic class.”
Bonviva is already approved as an effective and well-tolerated1 once-monthly oral tablet in over 38 countries worldwide. Oral bisphosphonates are the most commonly prescribed treatment for postmenopausal osteoporosis and recent studies show women* prefer once-monthly to once-weekly oral bisphosphonate treatment, finding it more convenient and easier to take over a long period of time.2,3
A minority of women may not be able to take their bisphosphonate orally. They may, for example, be unable to stay upright for the required length of time, or have swallowing problems.† For these women, Bonviva Injection offersan effective way of gaining the proven bone strengthening benefits of bisphosphonate therapy.
Andrew Witty, President of EU Pharmaceuticals, GSK said, “Bonviva is now the only treatment for postmenopausal osteoporosis offering physicians and patients throughout Europe both a tablet and injection option. Oral bisphosphonate therapy is the gold standard and studies have shown the majority of women prefer taking once-monthly oral Bonviva to a weekly treatment. However, for those women who are unable to take oral bisphosphonates, Bonviva Injection provides an effective and well-tolerated option.”
Bonviva Injection is presented as a 3mg/3ml solution in a pre-filled syringe and is administered once every three months by a healthcare professional as an intravenous injection over a 15 - 30 second period.
European Union marketing authorisation for Bonviva Injection is based on results from a 2 year study called DIVA (Dosing IntraVenous Administration).4 DIVA investigated the efficacy, safety and tolerability of Bonviva Injection compared to the once-daily oral formulation of Bonviva and found it to be highly effective and well-tolerated.4 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.5
GlaxoSmithKline http://www.gsk.com
Apr 2nd 2006
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