MannKind Corporation provided an update on the status of its new drug application (NDA) for Afresa, an ultra rapid-acting insulin that has completed phase-3 clinical trials. As previously announced, the company's internal goal was to submit the NDA to the Food and Drug Administration (FDA) by the end of February. Based on editorial decisions made during the final stages of preparing the dossier, the company decided to extend the submission date by approximately three weeks.
The document is fully drafted. However, during final review the company decided that it would be preferable to remove several tens of thousands of pages of back-up data from the submission and instead make this material available to the FDA upon request. This change will significantly reduce the size of the NDA and should make the NDA more reviewer-friendly.
"Although I am mindful of our goal to submit the NDA as quickly as possible, it is more important to me that we provide the FDA with a high-quality submission that can be efficiently reviewed," said Dr Peter Richardson, MannKind's Corporate vice president and chief scientific officer. "I am not willing to rush the final hyper-linking and quality-checking activities, especially when these efforts could potentially facilitate the FDA's review of our new drug application for Afresa."
Afresa is an ultra rapid acting insulin product that has completed phase-3 trials. The pharmacokinetic profile of Afresa sets it apart from all other insulin products.
MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer.