FDA Approves Raloxifene For Osteoporosis

The US Food and Drug Administration has cleared Eli Lilly's selectiveestrogen receptor modulator Evista (raloxifene) for marketing, within two weeks of its approval being recommended by an advisory committee (Marketletter December 1). The product should be available in 60mg tablets starting in January, according to the company. Lilly's share price was largely unchanged on the news, as the stock has already been boosted by the advisory panel meeting.

Evista has been tipped as a potential blockbuster in the osteoporosis prevention market as it offers estrogen-like activity in bone, but does not have the hormone's negative effects in the breast and uterus. It will compete with estrogen replacement products, notably market leader Premarin (conjugated estrogens) from Wyeth-Ayerst and Merck & Co's bisphosphonate Fosamax (alendronate). Sales of these agents were $860 million and $280 million respectively in 1996.

Fosamax sales have the potential to double in 1997, according to analysts, and the osteoporosis market as a whole is expected to expand with the advent of raloxifene and other new drugs. Osteoporosis affects about 28 million people in the USA, mostly older Caucasian and Asian women.