MannKind's much-watched inhaled insulin product Afrezza has received a complete response letter from the FDA. According to a release, the letter requests more information related to several areas of the NDA. The good news for MannKind is that the agency cited no safety concerns, but it did ask for updated safety data related to the drug. Additionally, the FDA asked for currently available clinical data that support the clinical utility of Afrezza, as well as data about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials.
MannKind CEO Alfred Mann notes that the company had planned a submission for its next-generation inhaler following its original NDA for Afrezza. The MedTone inhaler is currently used to deliver the drug; MannKind's new inhaler would be smaller, more effective and less expensive. "We will discuss with the FDA whether it is appropriate to use what would otherwise have been a supplemental NDA submission, which we had planned to make during the second quarter of this year, to address the agency's requests. If this approach is acceptable, we believe that this regulatory action will not have a significant impact on the timing of the commercial launch of Afrezza," explains Mann.
Analysts have had doubts all along about MannKind's ability to gain approval and market success with Afrezza. Pfizer once had its own inhaled insulin drug, Exubera, which the company eventually dumped due to low sales. MannKind hopes consumers will find the less bulky design of Afrezza's inhaler more appealing than Pfizer's offering.
The FDA missed its original January 16 deadline for its ruling on MannKind's, saying that it needed more time to complete its inspection of an insulin manufacturing facilities. MannKind's release did not clarify whether that inspection has been completed.
- here's MannKind's release