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Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis

- Shown to be highly effective in strengthening bones and protecting

against osteoporosis-related fractures, including spine and hip - Reclast reduced spine fractures by 70% and hip fractures by 41% compared

to placebo in study published in New England Journal of Medicine - Unique once-yearly dosing provides potential for significant compliance


- Osteoporotic fractures affect one in two women over 50(1) and are

associated with increased morbidity, mortality and healthcare costs

EAST HANOVER, N.J., Aug. 17 /PRNewswire-FirstCall/ -- Reclast(R) (zoledronic acid) Injection has been approved by the US Food and Drug Administration 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 US(1).

Unlike oral bisphosphonate therapies that have to be taken daily, weekly or monthly, Reclast is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment a patient can receive a full year's protection against the effects of osteoporosis -- a disorder that causes bones to break easily.

"The fact that Reclast is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis," said Felicia Cosman, MD, Professor of Clinical Medicine, Columbia University.

"For the first time we can ensure women receive a full year of the treatment they need to protect their bones," said Dr. Cosman.

The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the medicine in the European Union, under the brand name Aclasta(R). The European Commission generally follows the CHMP's recommendations and is expected to issue a final decision within three months.

The regulatory subm

SOURCE Novartis Pharmaceuticals Corporation

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