January 13, 2010 / 12:46 AM / 10 years ago

MannKind expects FDA to approve inhaled insulin

* CEO expects approval “within days” of plant inspection

* Label discussions with FDA still unresolved

* Partnership deal expected within months

SAN FRANCISCO, Jan 12 (Reuters) - MannKind Corp (MNKD.O) expects the U.S. Food and Drug Administration to approve its experimental inhaled insulin device “within days” of inspecting a manufacturing plant that supplies the insulin, the company’s chief executive said on Tuesday.

MannKind said on Monday the U.S. Food and Drug Administration would delay a ruling on whether to approve the product, called Afrezza, until it completed the inspection of third-party manufacturing facilities.

“My guess is an action letter will come within days of the inspection,” MannKind CEO Alfred Mann said during a presentation at the JP Morgan healthcare conference. “We have nothing from our side that’s due.”

Mann said the FDA has so far inspected one of the two N.V. Organon manufacturing plants that produce the insulin used in Afrezza.

He also said the company has not yet resolved discussions with the FDA over the labeling for Afrezza or whether lung function testing will be required, although he does not expect testing to be mandated.

The CEO said MannKind expects to secure a partnership deal for the product “in a number of months.” (Reporting by Deena Beasley; editing by Andre Grenon)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below