Lilly's Evista Backed By US Panel For Osteoporosis

A US Food and Drug Administration advisory panel has voted eight tofour in favor of approving Eli Lilly's new selective estrogen receptor modulator Evista (raloxifene hydrochloride) for the prevention of postmenopausal osteoporosis. Evista is being fast-tracked through registration in the USA, and the FDA is due to reach a verdict on the drug before the end of the year.

Raloxifene is leading the pack amongst a new generation of estrogen receptor modulators, which act as agonists in some areas of the body, eg bone, but inhibit the endogenous hormone's effects in other areas such as the breast and uterus. Lilly presented data from its trials of the drug which showed that raloxifene prevented bone loss in the total body, lower spine and hip compared to placebo plus calcium supplementation, and significantly increased bone mineral density, by around 2% to 3%. This is less than with estrogen replacement therapy or with Merck & Co's bisphosphonate drug Fosamax (alendronate).

Asked to vote whether BMD data was sufficient to secure approval or whether fracture data should be generated, the committee voted seven to four that this was acceptable, with one abstention. Lilly has ongoing trials to assess fracture rates.