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NEW YORK, May 23 (Reuters) - U.S. health regulators have delayed approval of Wyeth’s WYE.N experimental medicine for treating osteoporosis, requesting information about blood clots and stroke, the drug maker said on Friday.
The Food and Drug Administration issued a so-called “approvable letter” for Wyeth’s bazedoxifene.
According to Wyeth, the FDA asked for information similar to its request in December, when it also sent Wyeth an approvable letter regarding the company’s application to market bazedoxifene to prevent osteoporosis, a bone-weakening disease more common in women than in men.
Approvable letters generally mean the FDA is willing to approve an application once a company satisfies certain conditions.
Wyeth, one of the largest U.S. drug makers, said it has been working closely with the FDA to address the agency’s questions and expects to file a complete response by the end of the year.
“Today’s action is in line with our expectations,” Gary Stiles, chief medical officer of Wyeth Pharmaceuticals, said in a statement.
The FDA has told Wyeth it wants to convene an advisory panel hearing to review the pending drug applications for both treatment and prevention of post-menopausal osteoporosis, Wyeth said. Such committees commonly vet experimental medicines in a public forum before the agency gives its ruling.
Wyeth has had a mixed track record with its experimental pipeline as of late, winning approval for new medicines for depression and opioid-induced constipation, but seeing setbacks for other key products.
The company is trying to build its product line before its Effexor anti-depressant runs into generic competition in the next few years. (Reporting by Lewis Krauskopf; editing by John Wallace)