(New throughout; adds NEW YORK dateline)
NEW YORK May 23 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
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
"Today's action is in line with our expectations," Gary
Stiles, chief medical officer of Wyeth Pharmaceuticals, said in
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)