|Mannkind says FDA wants more info; will hold conference call|
|By Staff and Wire Reports|
|Monday, 15 March 2010 10:01|
A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.
The Complete Response letter related to the AFREZZA application requested several items, including information and currently available clinical data that support the clinical utility of AFREZZA and information about the comparability of the commercial version of the MedTone inhaler to the earlier version of this device that was used in pivotal clinical trials. The letter cited no safety concerns, but requested updated safety data related to AFREZZA. The letter also requested changes to the proposed labeling of the cartridges, foil pouches and cartons.
The letter did not require any additional pre-marketing clinical studies in order for the FDA to complete its review of the NDA. As recommended by the FDA, MannKind will request an End-of-Review meeting with the agency to discuss its approach for resolving the remaining issues.
“We are currently reviewing the Complete Response letter and fully expect that we will be able to respond to the FDA's requests in a timely manner,” said Alfred Mann, Chairman and Chief Executive Officer. “We had always planned to follow the original NDA for AFREZZA with a regulatory submission for our next-generation inhaler rather than launch with the commercial version of the MedTone device. We will discuss with the FDA whether it is appropriate to use what would otherwise have been a supplemental NDA submission, which we had planned to make during the second quarter of this year, to address the agency’s requests. If this approach is acceptable, we believe that this regulatory action will not have a significant impact on the timing of the commercial launch of AFREZZA. We will work closely with the FDA to answer quickly the agency’s questions and satisfy the requirements. We are committed to working with the FDA to make AFREZZA available to patients as soon as possible.”
Simos Simeonidis, Ph.D. Managing Director Senior Biotechnology Analyst at Rodman says: "The FDA issued a Complete Response Letter (CRL) on the Afrezza NDA, but it’s the “good” kind, meaning that the issues the FDA brought up can be addressed without significant delays. In addition, the FDA did not bring up the two issues most prominent in the bear theories for Afrezza, i.e. 1) that the product has major safety issues and 2) that current trials are not sufficient for approval. Obviously, a straight approval would have been the ideal scenario for MNKD holders, but as we have outlined in the past, including our report on 2/1/10, today’s news means that Afrezza approval is still very much alive, and with significant overhangs removed."
MannKind will host a conference call at 9:00 am EDT on March 16, 2010. To participate in the live call by telephone, please dial 888-955-8944 or 800-369-1120 and use the participant passcode: MANNKIND. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at www.mannkindcorp.com. A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing 800-889-9139. A replay will also be available on MannKind's website for 14 days.