MannKind’s diabetes drug Afrezza recommended by FDA advisory

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 13 to 1 to recommend that MannKind Corp’s (Nasdaq: MNKD) Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes.

The Committee also voted unanimously (14 to 0) to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the USA, noted MannKind.

MannKind ‘s share price more than doubled to $8.46 in extended trading in New York yesterday, having declined 17% to $4.02 on Monday in anticipation of a negative vote by the expert panel. The shares were suspended ahead of the Committee meeting.