FDA won't review Afrezza until July
MannKind is going to have to wait a little longer to find out its regulatory fate: the FDA has pushed off its review decision of the inhaled insulin Afrezza for another three months.
The company said in a statement on Monday that the FDA wants more time to review the application. Barron's reports that this is not a surprise for Cowen analysts Simos Simeonidis and Yatin Suneja, both of whom expect the regulator to approve the diabetes medication “in great part because of what is viewed as a ‘real need' for specific patient groups,” they said.
An FDA advisory panel endorsed the drug last week, surprising many, both because of the drug assessments posted online before the panel convened, and the fact that the FDA had already rejected the drug three times.