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.
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