MannKind announced Monday that the FDA issued a complete response letter regarding its application for the inhalable insulin Afrezza in the treatment of type 1 and type 2 diabetes.
The agency requested, among other items, "information and currently available clinical data that support the clinical utility of Afrezza," the company noted. The letter cited no safety concerns but requested updated safety data and changes to the proposed labelling.
MannKind CFO Matthew Pfeffer remarked that "we think the issues raised by the letter are completely addressable," adding that "if we are allowed to incorporate this information on the inhaler in our response, we can stay on schedule for the commercial launch."
Commenting on the news, Leerink Swann & Co. analyst Joshua Schimmer noted that "at this point, there is just uncertainty as to what the FDA is looking for." Schimmer also said that MannKind's intention to ask for an end-of-review meeting with the FDA to discuss how to resolve the remaining issues raises concerns that the matter will complicate the company's plans.
In addition, Hapoalim Securities analyst Jon Lecroy stated that "the FDA has been shifting to more comparable analysis of new drugs, rather than placebo analysis." Lecroy said he does not expect Afrezza to be approved and commented that although he believes inhalable insulin is effective, "Afrezza still has to be taken several times per day, so it's not any more convenient than injectable insulin."
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