Good news for MannKind as US FDA accepts firm's response on Afrezza

USA-based drugmaker MannKind received a boost last week when the US Food and Drug Administration accepted response to the complete response letter (CRL) issued by the agency on its inhaled insulin candidate, Afrezza (insulin human [rDNA origin]), which is being developed for treating type 1 and type 2 diabetes.

The agency informed the company that the resubmission will be treated as a class II review. Consequently, a decision from the FDA should be out within six months (target date: December 29, 2010). The resubmission included safety and efficacy data from recently completed studies on the candidate.

The FDA had issued a CRL earlier in the year to MannKind in response to the New Drug Application submitted in 2009 for Afrezza (The Pharma Letter March 16). The FDA asked MannKind for certain additional information and clinical data. 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 for updated safety data.