June 22nd, 2011

The Wall Street Journal reports:

The Food and Drug Administration is grappling with the novel question of whether a Novartis AG gout-pain drug should be marketed when patients receiving just one injection had a higher rate of serious infections in clinical studies.

An FDA advisory committee Tuesday voted 11-1 against approving the drug, called Ilaris, because of the safety concerns. However, the panel of outside experts unanimously found the drug was effective and several committee members said they hoped that the company could present more data or that a way might be found to approve the drug with restrictions. The FDA often follows the advisers’ recommendations but isn’t required to.

Safety was at the center of the panel’s debate. Michael A. Carome, a health researcher at Public Citizen, told panel members, “The drug has serious, life-threatening risks” and its effects “may be protracted.”

However, Novartis presented data showing Ilaris could prevent gout flare-ups more effectively than other treatments in many patients. And several panel members appeared to agree.

“There clearly is a niche for this” drug, said Lenore M. Buckley of Virginia Commonwealth University.

For the rest of the story read, The Wall Street Journal