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Once-yearly osteoporosis drug approved by FDA

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The FDA has approved Novartis' drug Reclast as the first once-yearly treatment for postmenopausal osteoporosis, Novartis announced in a press release.

Reclast (zoledronic acid) is administered once a year via 15-minute intravenous infusion.

The FDA based its approval on data from the 3-year Pivotal Fracture Trial, which showed that zoledronic acid increased bone strength and reduced fracture rates in areas typically affected by osteoporosis, including the hip, spine and nonspine sites, such as the wrist and ribs.

Zoledronic acid is the only drug shown to reduce fracture rates across all three areas, the release said.

In the study, which involved more than 7,700 women, zoledronic acid reduced the risk of spine fractures by 70% and hip fractures by 41%. In particular, spine fractures were reduced by 60% at 1 year follow-up, 71% at 2 years and 70% at 3 years.

Bone mineral density significantly increased by 6.7% for the spine and by 6% in the hip among women receiving zoledronic acid compared to those treated with placebo.

The FDA approval comes after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in July recommending approval of the drug for marketing in the European Union under the brand name Aclasta.

The European Commission generally follows the CHMP's recommendations and is expected to issue a final decision within 3 months, according to the release.

For more information:

• Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. New Engel J Med. 2007;356:1809-1822.