Valencia-based MannKind Corp.'s inhaled diabetes treatment won the backing of a panel of U.S. regulatory advisors, boosting the company’s long-running effort to get its first product on the market.
Advisors to the Food and Drug Administration voted 13 to 1 that the drug, Afrezza, should be approved for Type 1 diabetes. It voted 14 to 0 that it should be approved for the more common Type 2 diabetes. The FDA doesn’t have to follow the panel’s recommendation. FDA staff raised concerns in a report March 28 that the drug may affect lung function. Staff also raised concerns about missing data from a study on Type 1 diabetes patients.
Though some panel members who backed approval expressed reservations about potential safety risks, they said MannKind demonstrated that the drug works. The advisors also said the benefit of an alternative to insulin injections outweighed their concerns or could be addressed in the medicine’s labeling.
MannKind has spent more than seven years trying to gain approval for the treatment. The FDA rejected the drug twice, most recently in 2011, after the company decided to switch inhalers during the review process.
If approved, Afrezza may generate $583 million in 2018, according to the average estimate of analysts compiled by Bloomberg. The FDA is expected to decide by April 15 whether to clear the drug for sale.
MannKind shares declined 17% to $4.02 on Monday, its biggest single-day fall since October 2012, as investors were concerned that the panel may react negatively to the company’s drug. Trading was halted Tuesday in advance of the panel’s meeting.
Afrezza would compete with Eli Lilly & Co.'s Humalog and Novo Nordisk’s Novolog, both injected insulins. Novolog generated $3 billion in sales last year and Humalog brought in $2.6 billion, according to data compiled by Bloomberg. Many diabetics begin treatment on an older drug called metformin, a pill that can lose effectiveness over time.