US FDA backs Pfizer osteoporosis drug

ROCKVILLE: A Pfizer Inc drug rejected by US regulators three years ago won support from an expert advisory panel on Monday for treating women with the bone-thinning disease osteoporosis. The committee voted 9-3 that the drug, Fablyn, offered benefits that outweighed risks such as blood clots. One member abstained. Pfizer developed the drug with technology from Ligand Pharmaceuticals Inc. Most panel members said they could not tell if a higher rate of deaths among Fablyn patients represented a true increase. Many said the drug could appeal to some women as an alternative to other therapies with their own hazards. "The panel felt, overall, women would benefit from having this drug available," said Dr. Sandra Carson, the panel's chairwoman and the director of reproductive medicine and infertility at Women and Infants Hospital of Rhode Island. The Food and Drug Administration will weigh the advice before deciding if Fablyn can be sold. The FDA usually follows panel recommendations. A ruling is expected in October. More than 200 million people worldwide have osteoporosis, which weakens bones. Panel members felt Fablyn would be most likely to help postmenopausal women with osteoporosis who were at high risk of fractures, Carson said. Some said the drug should be reserved for women who do not tolerate other medicines known as bisphosphonates. That category includes Merck & Co Inc's Fosamax, which is sold generically as alendronate. Pfizer, the world's largest drugmaker, is looking for new medicines to help it survive generic competition as early as 2011 to cholesterol fighter Lipitor, which has sales of $13 billion a year. Cowen and Co estimates Fablyn will garner annual sales of $250 million by 2012. The FDA rejected Pfizer's bid to sell the once-a-day pill for osteoporosis in 2005 with the name Oporia and again in 2006 for vaginal atrophy. Pfizer said the agency was concerned at the time about a possible risk of endometrial cancer. In Pfizer's latest data, 6.4 percent of placebo patients developed new or worsening fractures within three years. That compared with 3.8 percent given the proposed Fablyn dose. But more women died while taking a lower dose of Fablyn than with a placebo. Pfizer said the difference was due to a small number of deaths in the placebo group in one region and was not linked to the drug. Seven panel members said they were unable to tell if the finding reflected a true mortality increase with the drug. Four panelists said the data did not support a higher rate, while two said it did. The panel also voted 9-2, with two abstentions, that blood clot concerns were no greater for Fablyn than with hormonal drugs already sold for osteoporosis or menopause symptoms. Consumer representative Merrill Goozner of the Center for Science in the Public Interest said too little was known about serious risks from Fablyn. "I can't really figure out what the risks are based on the data," said Goozner, who voted against the drug. Fablyn belongs to a class of drugs known as selective estrogen receptor modulators, or SERMs, which includes Eli Lilly and Co's osteoporosis drug, Evista. Fablyn's generic name is lasofoxifene. If Fablyn is approved, Ligand will receive a milestone payment and royalties of 3 percent of net sales. Pfizer spokesman Jack Cox said the company "will continue to work with FDA on any outstanding questions." Pfizer shares gained 3.4 percent to close at $19.14 on the New York Stock Exchange, while Ligand shares rose 10.9 percent to close at $3.56 on Nasdaq.

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