US marketing delay for MannKind's Afrezza and Cephalon drops Nuvigil for jet lag

4 January 2011

The US Food and Drug Administration disappointed two US drugmakers last week as it announced that it needs more time to assess MannKind Corp’s (Nasdaq: MNKD) New Drug Application for Afrezza (insulin human [rDNA origin]) inhalation powder and issued a complete response letter (CRL) for Cephalon’s (Nasdaq: CEPH) Nuvigil (armodafinil) NDA.

The agency said it could not complete the review of Afrezza, being developed for the treatment of type 1 and 2 diabetes, by the action date of December 29, 2010, and will require approximately four additional weeks to do so.

The FDA accepted MannKind’s re-submitted NDA in July this year after issuing a CRL to MannKind on Afrezza in March 2010 due to insufficiency of data. In issuing the CRL, the agency asked for information about the commercial version of the company’s MedTone inhaler, which is different from the one used during clinical trials. Furthermore, the FDA requested updated safety data.

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