The FDA has accepted MannKind's resubmission of its NDA for the inhaled insulin drug Afrezza and set a PDUFA action date of December 29, 2010.
The much-watched Afrezza NDA received a complete response letter from the FDA in March. At that time the agency requested more information related to several areas of the NDA, including updated safety data related and additional clinical data that support the clinical utility of Afrezza. Regulators also wanted data about the device Mannkind planned to use for deliver the drug. The company submitted Afrezza for use with the MedTone inhaler, but the FDA wanted more data on the company's "Dreamboat" device, a smaller and more efficient inhaler the company plans to launch once the drug is approved.
MannKind said today that it has submitted clinical data from a recently-completed efficacy study in patients with type 1 diabetes as well as updated pooled safety data related to Afrezza, along with information on the comparability of MannKind's "Dreamboat" delivery system to the MedTone device that was used in pivotal clinical studies.
"We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA," said Mannkind CEO Alfred Mann in a statement. "We will continue to work closely with the FDA during this final stage of the review process. We firmly believe AFREZZA has the potential to address a poorly-met need in diabetes therapy. Our primary goal is to make this novel therapeutic option available to patients as soon as possible."
- take a look at Mannkind's release