Five days after its end of review meeting with the FDA on May 4 regarding its Afrezza inhaled insulin, MannKind Corporation held a conference call to update its progress and financial situation. During the call, Alfred Mann characterized the meeting as “positive and collaborative, resulting in a redirection of the Type 2 trial that should enable us to support use of AFREZZA as an alternative to oral therapies in early Type 2 diabetics.”
MannKind received a complete response letter (CRL) in regards to its Afrezza NDA in January, 2011 in which the FDA requested additional safety data and performance data for its new Dreamboat inhaler. The original studies were conducted with the MedTone inhaler. During the end of review meeting, according to the company, the FDA spent a good deal of time discussing a head-to-head comparison of the two inhalers.
“The agency agreed that the observed changes in pulmonary function do not differ between Type 1 and Type 2 patients. They also considerably simplified the requirements of pulmonary function testing by requiring spirometry alone as compared to the previous pulmonary safety studies, in which we also collected a more complicated, less generally available measurements DLCO and DLZ,” said President and CEO Hakan Edstrom; “This gives us the opportunity to implement the Dreamboat versus MedTone bridge in just the Type 1 study.”
Mann said that he remained committed to the Afrezza project and is “exploring ways to make moneys available” in light of additional expenses due to the additional trials required. Edstrom noted that the company will use data from these additional trials for its European submission, which he expects to save some money. He said that the company is ready to begin studies as soon as the details are finalized and will make further decisions once they see the FDA’s written minutes from the meeting, which they expect to have in about 3 weeks.
During the Q&A session, Edstrom indicated that MannKind hopes to complete the trials by the end of 2012.
