California-headquartered MannKind unveiled the Dreamboat inhaler in 2009, basing its design on feedback it received from from patients in clinical trials of the diabetes drug.
Shortly after, according to Reuters, the firm updated its Afrezza dossier with in vitro performance data for the new device amid concerns the US Food and Drug Administration (FDA) would ask for clinical data proving that the two delivery systems were equivalent.
Evidently this effort was not enough for the FDA which, issued the firm with a complete response letter earlier this week.
In its letter the agency asked MannKind to conduct two more studies with the Dreamboat inhaler, with at least one including a patient cohort using MedTone to allow for a head-to-head comparison of data.
The FDA also wants more data on Dreamboat’s performance in terms of usage, handling, shipment, storage and safety as well as information on any proposed user training instructions MannKind plans to introduce.
In his response CEO Alfred Mann was fairly upbeat, explaining that: “While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program.”
He also pointed out that the firm was already started trials of the dreamboat device, Affinity 1 and 2, which he said are consistent with the direction we received in the complete response letter.
“We plan to meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency's questions about patient use and robustness of the next-generation device."
News of the rejection, which saw MannKind’s share price fall 43 per cent to $5.15 in after hours trading on the NASDAQ, was less well received by analysts, however.
Jon Lecroy of Hapoalim Securities told Reuters that: "It's not the worst case scenario, but it's pretty bad,
"You're looking at least a year delay before they can refile, would be my expectation. And that would start a new review cycle, so I would say it's probably delayed two years."
Jason Butler from JMP Securities agreed, telling the Wall Street Journal that he now does not expect approval of Afrezza before 2012.