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FDA panel gives thumbs-up to Santa Clarita's MannKind

Inhaled diabetes treatment passes one hurdle for approval

Posted: April 1, 2014 6:26 p.m.
Updated: April 1, 2014 6:26 p.m.

A Food and Drug Administration committee gave Santa Clarita-based MannKind Corp. a thumbs-up Tuesday for its innovative inhaled diabetes treatment.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend that Afrezza be approved by the FDA.

A final decision by the FDA is expected within a couple of weeks.

If approved, Afrezza would be the first ultra-rapid-acting mealtime insulin therapy available in the United States. And Afrezza would immediately go into commercial production, said Chief Financial Officer Matthew Pfeffer.

After some seven years of development and clinical testing, a lot is riding on a green light from the FDA.

And if Afrezza’s inhalation device is approved, the technology lends itself to other projects that MannKind has in the pipeline.

“One is a pain product,” Pfeffer said. “It’s in a very early stage, but it lends itself to our technology to get something into the bloodstream very, very quickly to provide fast pain relief.”

Afrezza peaks in the bloodstream within 12 to 15 minutes of inhalation. Currently, standard treatment injections take 90 to 150 minutes to peak.

If approval is won to produce Afrezza, the next step is for MannKind to partner with a large worldwide pharmaceutical company that already has marketing and distribution infrastructure in place.

One week ago, MannKind’s stock climbed to almost $6 a share. On Monday, shares fell to $4.02 as investors became nervous when some analysts reported some panel members expressed reservations about potential safety risks.

But MannKind was confident in its product or it wouldn’t have made the application for FDA review, Pfeffer told the SCV Business Journal last week.

Though some panel members who backed approval expressed reservations about potential safety risks, they said MannKind demonstrated that the drug works, reported Bloomberg News.

Advisers also said the benefit of the inhaled powder diabetes treatment over insulin injections outweighed their concerns, or any issues could be addressed in the medicine’s labeling, the news group said.

“We are pleased with the advisory committee’s approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review,” said Alfred Mann, chairman and chief executive officer of MannKind, in a statement issued to the news media.

“We look forward to working with the FDA as they complete their evaluation of Afrezza. Diabetes is a major health problem in the United States, and we are committed to bring Afreeza to the many patients who might benefit from this novel product,” Mann said.



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