FDA panel rejects approval for Forest pulmonary drug due to safety questions

FDA panel rejects Forest lung disease drug

WASHINGTON — Federal health experts on Wednesday sided against an experimental lung disease treatment from Forest Laboratories because of potentially dangerous side effects.

The Food and Drug Administration’s panel of lung experts voted 10-5 against approving Forest’s drug Daxas for pulmonary lung disorder, often called “smoker’s cough.”

The FDA is not required to follow the group’s advice, though it often does.

The rejection followed an earlier vote of 9-6 that Daxas appeared effective for treating the disease, according to an FDA spokeswoman.

Panelists raised concerns about possible side effects, including suicide, weight loss and cancer. Those problems were more frequent among Daxas patients than those taking an alternative drug in company studies.

The FDA is expected to make a decision on the drug by mid-May.

Forest Labs Chief Operating Officer Larry Olanoff said the company was “disappointed” by the final vote, but said it did not preclude approval for the drug.

“We didn’t see this as a unanimous vote against approval,” said Olanoff. “The questions raised we think are clearly negotiable with the agency.”

Forest Labs purchased the U.S. rights to sell Daxas last summer from drugmaker Nycomed for $100 million. Nycomed will also receive royalties on U.S. sales.

Chronic pulmonary obstructive disorder affects roughly 25 million people in the U.S.

Shares of New York-based Forest Labs fell $2.86, or 8.8 percent, to $29.51 in after-hours trading Wednesday.