The FDA has asked for additional data that support the clinical utility of the inhalable insulin candidate as well as for information on the comparability of the commercial version of the MedTone inhaler to the earlier version used in trials.
MannKind, which expected completion of regulatory review earlier this year, said it already has the additional clinical utility data the FDA has requested and, according to CEO Alfred Mann, intended to revise its application relating to the delivery device.
Mann explained that: “We had always planned to follow the original [new drug application] NDA for Afrezza with a regulatory submission for our next-generation inhaler rather than launch with the commercial version of the MedTone device.”
He added the firm will ask the FDA if the issues can be addressed in a supplemental NDA (sNDA) and predicted that, if accepted by the agency, such an approach will not have a significant impact on the timing of commercial launch.
Mann concluded by saying that: “[MannKind is] committed to working with the FDA to make Afrezza available to patients as soon as possible.”
But, while a resilient response is characteristic of a firm that has battled on as the only remaining player in the inhalable insulin market after the failure of Pfizer’s Exubera and Lilly’s Air, investors, it appears, are less optimistic.
News of the FDA letter was accompanied by a 16 per cent drop in MannKind's share price in trading on the Nasdaq Stock Exchange yesterday.
Clinical Utility
The problem, according to Hapoalim Securities analyst Jon LeCroy, is the term "clinical utility" which, he told the Wall Street Journal, implies the “FDA is questioning how much of a needed medication this is.”
LeCroy also suggested that: "If the response was an easy one to do, they wouldn't need to meet with the FDA," adding that: "We're assuming this is not going to be an approvable product."
Others were less downbeat about Afrezza’s prospects. Simos Simeonidis, an analyst with Rodman & Renshaw, told Bloomberg that the agency’s comments were “benign” stressing that the lack of safety concerns and the fact that more trials would not be required were positive for MannKind.