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POSTMENOPAUSAL OSTEOPOROSIS
TREATMENT |
Once-monthly pill for postmenopausal osteoporosis okayed in Europe
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BY OUR PHARMA CORRESPONDENT
20 September,2005: European Union marketing authorisation has been granted for Bonviva 150mg for the treatment of postmenopausal osteoporosis, Roche and GlaxoSmithKline (GSK) announced.
Bonviva (ibandronic acid) is the first and only once-monthly tablet for the
treatment of postmenopausal osteoporosis. This announcement follows FDA and Swissmedic approval earlier this year.
Bonviva, a potent and highly effective bisphosphonate is the first ever oral treatment administered as one tablet once a month for any disease. This means osteoporosis patients will only have to take 12 Bonviva tablets a year versus 52 or 365 required with current weekly or daily bisphosphonate treatments. This is particularly important as many patients find osteoporosis therapy inconvenient, which may help to explain why up to two-thirds of patients stop taking their osteoporosis treatment within a year, foregoing the bone building benefits these drugs can only provide over time.
Poor adherence has a negative effect on osteoporosis treatment outcomes including lower gains in bone mineral density (BMD), smaller decreases in the rate of bone turnover and a significantly greater risk of fractures.
Bonviva delivered a reduction in the occurrence of new vertebral fractures of 62% over three years at a 2.5mg daily dose. Bonviva is also the only nitrogen-containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day, said an official release.
European Union marketing authorisation for once monthly oral Bonviva is based on 2-year results of the MOBILE (Monthly Oral iBandronate In LadiEs) phase III study in 1,609 women with postmenopausal osteoporosis. The study shows the monthly dose was highly effective and well tolerated over two years and is actually statistically superior at increasing bone mineral density (BMD) compared to the daily dose.
Bonviva (known in the US as Boniva) 150mg once-monthly oral is indicated for the treatment of postmenopausal osteoporosis in Europe. It is anticipated the UK and Germany will be first to launch the once-monthly formulation in the EU. In the US, once-monthly Boniva 150mg is indicated for the treatment of osteoporosis in postmenopausal women. In the USA and in Europe, Bonviva is co-promoted by GSK.
MOBILE (Monthly Oral iBandronate In LadiEs) is a two-year, randomised, double-blind trial comparing the efficacy and safety of monthly oral doses of ibandronate (100mg on a single day; 100mg as separate 50mg doses on two consecutive days; or 150mg on a single day) versus the oral daily regimen (2.5mg), approved by the FDA and European Commission, in 1,609 women with postmenopausal osteoporosis. The primary endpoint was analysed at 1 year. One year results from MOBILE were recently published in the Journal of Bone and Mineral Research and full two year results were presented at the Annual European Congress of Rheumatology, Vienna, Austria 8-11 June 2005.
• Bonviva, a potent bisphosphonate, has been studied to date in clinical trials involving over 12,000 osteoporosis patients
• The ongoing clinical development programme is evaluating monthly oral and bi-monthly/quarterly intravenous dosage regimens in women with postmenopausal osteoporosis
• Once-daily Bonviva is indicated for the treatment and prevention of osteoporosis in postmenopausal women by reduction of elevated bone turnover, increasing bone mineral density and reduction of the incidence of vertebral fractures
• Studies specifically designed to demonstrate reductions in non-vertebral or femoral neck fractures have not been conducted with Bonviva
• Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer
• Bonviva (known in the US as Boniva), was approved by the US Food and Drug Administration in March 2005. In the US, Boniva 150mg is indicated for the treatment of osteoporosis in postmenopausal women.
In December 2001, Hoffman-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology.
BY OUR PHARMA CORRESPONDENT |
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