Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has received minutes from pre- New Drug Application (“NDA”) meetings with the Food and Drug Administration (“FDA”) for the acute treatment of migraine for Qtrypta. The purpose of the meetings was to confirm the completion of all requisite studies, as well as the proposed clinical, non-clinical, and chemistry, manufacturing, and controls (“CMC”) content and format of the company’s NDA submission, which the company expects to make in December 2019.
“We are encouraged by the pre-NDA minutes received from FDA after our collaborative meetings. This is an important milestone as we head into the final stages of completion of the NDA,” said Hayley Lewis, Senior Vice President, Operations. “These minutes reflect discussions made between Zosano and FDA on the format and content of the NDA to help ensure all elements of submission are met.”
The company was granted two separate pre-NDA meetings to discuss the development program. A face to face meeting was held with the FDA in September to discuss the nonclinical and clinical portions of the program. A second pre-NDA meeting request was granted to discuss CMC, and FDA recently provided its written responses to the company’s questions in lieu of holding an in-person meeting. Based on the feedback from the FDA, the company believes the information included in its planned NDA will be sufficient for the FDA to file the NDA for substantive review.