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Wyeth gets 2nd FDA request for more data on osteoporosis drug

Wyeth gets 2nd FDA request for more data on osteoporosis drug

U.S. regulators handed Wyeth its latest setback, demanding the drug maker answer more questions before it can rule on its experimental osteoporosis medicine, the company said Monday.
The news Monday marks the fourth time since April that the Food and Drug Administration has rejected approval of a Wyeth drug, demanded additional information or required an entire new study.
Wyeth said the FDA had sent the company a second "approvable" letter for bazedoxifene, which stated it won't consider approving the drug for preventing postmenopausal osteoporosis until Wyeth explains stroke and blood clot problems, Wyeth said.
FDA sent the first "approvable" letter in April, requesting more information. However, Wyeth's June response didn't resolve all questions, and the FDA now wants further analyses, Wyeth said.
Issues with the company's data collection and reporting also are unresolved.
Wyeth said the FDA had not considered other data _ covering nearly 1,000 women _ which it had submitted since October. It said that data supports approval.
Osteoporosis thins bones, particularly in the years right after menopause. That raises the risk of fractures, disability and earlier death.
FDA in September accepted a separate application for bazedoxifene to treat postmenopausal osteoporosis after it has begun; a decision is expected in May.
Company spokeswoman Natalie de Vane said Monday that Wyeth continues to work with the FDA on issues surrounding other rejected drugs.
On Aug. 10, FDA rejected Wyeth's experimental schizophrenia drug, bifeprunox, saying it was not as effective as other drugs on the market. Wyeth had said research showed the drug stabilized patients without causing the weight gain common with schizophrenia drugs.
De Vane said Wyeth, development partner Solvay Pharmaceuticals Inc. of Marietta, Ga., and the FDA are discussing the drug's prospects. She could not say whether an additional study will be required.
On July 16, the FDA declined to approve Pristiq _ which would have been the first nonhormonal drug for menopause symptoms _ without further testing. The agency wants more information on Pristiq's effects on the heart and liver because a very small number of women in patient tests had serious heart or liver complications.
FDA is requiring a new clinical trial of one year or longer, meaning Wyeth cannot get Pristiq approved as a menopause drug until mid-2009 or later.
The company has been counting on Pristiq to rebound from a huge drop in sales of its former top-selling drugs, Premarin and Prempro, after the federal Women's Health Initiative in 2002 linked Prempro to higher rates of heart attacks, strokes, breast cancer and other problems.
Meanwhile, a patent dispute over Wyeth's heartburn drug Protonix intensified Monday when the company said it would sue to recover lost profits from sales of Teva Pharmaceutical Industries Ltd.'s just-launched generic version.
Wyeth did get two new drugs approved this spring. Lybrel _ the first hormonal birth control pill meant for continuous use _ and Torisel _ for kidney cancer _ both won approval in May.
In abbreviated trading Monday, Wyeth shares fell $1.41, or 3 percent, to $45.45.
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http://www.wyeth.com


Updated : 2021-04-15 04:34 GMT+08:00