VALENCIA, Calif. ( TheStreet) -- U.S. regulators have delayed the approval of an inhaled insulin drug and device from MannKind Corp. ( MNKD), the company said Monday. The U.S. Food and Drug Administration asked MannKind to provide updated data on the safety and efficacy of its Afrezza device and additional information about the inhaler used to deliver the insulin to the lungs. The FDA, however, did not ask for new clinical trials, MannKind said in a statement. MannKind shares fell 7% to $9.71 in early Monday trading. The announcement of FDA's complete response letter for Afrezza comes two months past its original Jan. 16 approval decision deadline. In early January, MannKind said FDA requested more time for the Afrezza review, in part, to complete inspection of a European manufacturing facility that makes the device's insulin. MannKind's statement Monday does not mention whether that inspection was completed. "We are currently reviewing the Complete Response letter and fully expect that we will be able to respond to the FDA's requests in a timely manner," said MannKind CEO Alfred Mann. MannKind is seeking FDA approval for Afrezza as a drug/device for the treatment of patients with Type 1 and Type 2 diabetes.
The drug-delivery technology that enables Bydureon to be dosed so infrequently comes from Alkermes ( ALKS), which will receive royalties on sales of the drug when approved. Bydureon and Novo Nordisk's ( NVO) recently approved Victoza belong to the GLP-1 class of injectable diabetes drugs intended to control blood sugar in Type 2 diabetes medicines. Victoza requires a once-daily injection. Amylin shares closed Friday at $20.26; Alkermes shares closed at $12.21. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.