Novartis once-yearly Reclast preserves bone mass, provides fracture protection in postmenopausal osteoporosis, long term data show

Swiss drug major Novartis (NOVN.VX) presented new six-year data reinforcing the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis over the weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Ontario, Canada.

The latest research comes just days after the US Food and Drug Administration issued a warning on the long-term use of bisphosphonates, a class of drugs that includes the injectable Reclast, calling for new labeling about the possible risk of atypical thigh bone (femoral) fracture in patients (The Pharma Letter October 14).

Reclast Injection was approved by the US Food and Drug Administration in August 2007 as the first and only once-yearly medicine for postmenopausal osteoporosis, offering an important new approach to the treatment of a bone disease affecting eight million women in the USA, and in the European Union, where it is sold at Aclasta, in October the same year. Zoledronic acid, the active ingredient in Reclast, is also available under the trade-name Zometa for use in oncology indications. Second-quarter 2010 sales of Reclast/Aclasta (zoledronic acid) for osteoporosis rose 23% year-on-year to $142 million;