January 16, 2009 / 10:55 PM / in 11 years

REFILE-UPDATE 1-FDA not ready to OK Pfizer osteoporosis drug

(Corrects typographical error in headline to “osteoporosis”)

NEW YORK, Jan 16 (Reuters) - U.S. health regulators are seeking additional information from Pfizer Inc (PFE.N) on its long-delayed, experimental osteoporosis drug, lasofoxifene, before deciding whether to grant approval, the world’s largest drug maker said on Friday.

Pfizer did not characterize the type of information that the Food and Drug Administration was seeking or say whether the agency was asking for an additional clinical study, which would mean a lengthy delay.

“Pfizer is reviewing the letter and will work with FDA to determine the appropriate next steps regarding the company’s application,” Pfizer said in a statement.

The FDA rejected the drug, which Pfizer hopes to sell under the brand name Fablyn, in 2005.

Pfizer submitted the current application for lasofoxifene to be used by post-menopausal women who are at increased risk of a fracture in December of 2007. An FDA scientific advisory panel voted 9-3 in September to recommend approval, saying there is a population of post-menopausal women with osteoporosis for whom the drug’s benefits likely outweigh the risks.

The agency typically follows the advice of its expert panels, but has rejected recommended medicines.

European regulators are also reviewing the medicine.

Analysts have largely kept out Fablyn sales projections from their Pfizer forecasts due to the uncertainty surrounding the medicine.

Lasofoxifene belongs to the same class of drugs as Eli Lilly and Co’s (LLY.N) Evista, known as SERMS, or selective estrogen receptor modulators. Evista had sales of $265.7 million in the third quarter of 2008. (Reporting by Bill Berkrot, editing by Leslie Gevirtz)

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