Inhalable Insulin Exubera Approved By FDA

Filed in archive Drugs, Vaccines and Therapeutics on January 27, 2006

After more than a decade of research, the US FDA approved the first inhalable version of insulin. The novel alternative to injectable insulin for the treatment of type-1 and type-2 diabetes has been developed by Pfizerwith Sanofi-Aventis and Nektar Therapeutics, and is to be marketed as "Exubera".

"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."

There is still one caveat:

Use of rapid-acting inhaled insulin will not replace the need to occasionally inject the hormone, according to the FDA. And diabetics would have to continue pricking their fingers to test blood sugar levels.

Pharma's Cutting Edge Blog provides a comprehensive review of the newly-approved Exubera label provided by the FDA.

Research to produce even better versions are still ongoing, with at least four other companies developing their versions of own inhalable insulin: Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S.

Photo: From Pfizer, viaTripleHelix