FDA panel backs stronger benefit claims and safety profile for inhaler drug Spiriva

more images

more images

FDA panel backs safety, benefits of Spiriva

WASHINGTON — Federal health experts on Thursday brushed off lingering safety questions about a popular inhaler drug and suggested it carry bolder benefit claims.

The Food and Drug Administration’s panel of lung specialists voted 11-1 in favor of new labeling about the benefits of Boehringer Ingelheim’s Spiriva Handihaler, which is approved to treat lung disease.

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

The German company submitted studies to the FDA showing Spiriva reduces specific side effects of chronic obstructive pulmonary disease, such as coughing, wheezing and shortness of breath.

“I thought both trials showed unequivocal evidence of benefit,” said panelist Daren Knoell, a pharmacy professor at Ohio State University.

Boehringer said in a statement it was pleased with the panel’s vote and would continue working with the FDA as it completes its review. A company spokeswoman declined to disclose the expected date for an FDA decision.

Spiriva is co-marketed in the U.S. by Pfizer Inc., the world’s largest drugmaker.

While Thursday’s meeting was prompted by Boehringer’s request for bolstered labeling claims, FDA regulators also asked the panel to examine conflicting evidence about whether Spiriva increases the risk of heart attack, stroke and death.

An analysis of multiple studies published in the Journal of the American Medical Association last year suggested increased risks with the inhaler. But panelists said a more definitive, 6,000-patient trial by the company did not show increased death, and suggested it can actually reduce that risk.

Panelists voted 11-1 that the company’s data “adequately address” concerns about increased stroke. They voted 11-0, with one abstention, that the same study addresses the issue of increased risk of heart attack.

Panel chair Dr. Mark Brantly said the company might eventually be able to win approval for a claim about the drug’s lifesaving powers.

“We encourage this be pursued as an indication in the future as an important outcome,” said Brantly, a professor of lung care at the University of Florida.