U.S. FDA advisers recommend Mannkind's inhaled diabetes drug Afrezza

by Reuters
Tuesday, 1 April 2014 21:47 GMT

(Adds comments from panelists at meeting)

HYATTSVILLE, Md., April 1 (Reuters) - Mannkind Corp's inhaled diabetes drug Afrezza is safe and effective for some diabetes patients with either the type 1 or type 2 form of the disease, U.S. health advisers said on Tuesday in recommending its approval for sales in the United States.

The Food and Drug Administration's advisory panel, in a 13-1 vote, backed the rapid-acting insulin treatment for adults with type 1 diabetes despite lingering concerns over long-term safety and data that showed the drug did not work any better than traditional insulin.

In a 14-0 vote, it also supported Afrezza for adults with the more common type 2 form of the disease, saying the benefits of the alternative therapy over current insulin drugs were clearer.

The FDA, which does not have to follow its panel's advice, is expected to make its approval decision by April 15.

Overall, the panel of outside advisers agreed with the drugmaker's argument that the whistle-sized inhaler offered a crucial alternative for many diabetics whose current treatment involves painful and cumbersome injections.

Panelists said the device could be especially helpful for patients who have problems giving themselves shots - such as poor eyesight or arthritis in their hands - or who have an extreme phobia of needles.

"There likely are circumstances under which Afrezza would be effective... but not simply in all patients," panel Chairman Robert Smith, an endocrinologist and professor of medicine at Brown University.

Panelists expressed concern with some potential side effects of the drug and said there was still not enough data about the possible link between the drug and lung cancer, calling for more long-term study even if the FDA approves the drug for U.S. sales.

"It's very important to follow this up," Smith said.

Shares of Mannkind were halted on Tuesday pending the outcome of the FDA panel's votes. They closed at $4.02 on Monday on Nasdaq. (Reporting by Susan Heavey; Editing by Peter Cooney)

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