The FDA has rescheduled its end-of-review meeting with MannKind Corporation regarding Afrezza inhaled insulin for May 4, 2011. The agency had earlier cancelled the meeting, which had been scheduled for April 15, due to a potential government shutdown.
At one time, the FDA had planned to complete its review by December 29, 2010 but requested additional time to review the data. It then issued a complete response letter for Afrezza in January, 2011 and asked for additional information.
After receiving notice of the May 4 meeting date, CEO Alfred Mann said, “We are pleased that the Agency has come up with a prompt solution, allowing us to continue preparing to implement their input into our planned studies. Fortunately the new schedule results in only a brief delay. We will continue working with the FDA to complete the regulatory process for AFREZZA.”
Read the MannKind press release.
