MannKind Corporation recently accounced that it has encountered a disappointing setback in its efforts to bring Afrezza to market. The FDA, it turns out, wasn’t able to sign-off on the company’s new drug application for the ultra rapid-acting form of inhaled insulin by January 16, the date the FDA had previously set for itself as a deadline for making this decision.
Apparently, the FDA has not completed inspecting the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind.
The FDA “must complete this inspection before it can finalize its review of our NDA,” said Alfred Mann, Chairman and CEO of MannKind. “To our knowledge, all other FDA inspections are complete. There are no pending answers to any FDA questions or other deliverables due on MannKind’s part.”
The FDA did not set a new date for completing the NDA.
Just one week before the FDA’s surprising announcement, Mannkind had suggested that FDA approval was in the bag.
According to Pharmalot, Mann has bet nearly half of his $2 billion fortune on Afrezza. Many competitors have given up on inhaled insulin products since Pfizer’s fiasco with a similar product, Exubera.
Some analysts were skeptical about the prospects for Afrezza in light of the recent surprise. For example, Hapoalim Securities’ Jon LeCroy said, “the fact that there is now no definite time-line for approval (is) a major negative, as drugs that have a missed PDUFA often take months to years to receive a final decision.”
However, Simos Simeonidis at Rodman & Renshaw believes there is a 75% chance the FDA will approve the drug this year.
Afrezza achieves peak insulin levels within 12-14 minutes of administration, which mimics the release of meal-time insulin in healthy individuals.