Advisors to the
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
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.