Arecor Therapeutics Receives Positive FDA Feedback on AT307 Injectable Medicine
By Joe Hoppe
Arecor Therapeutics recently announced that Hikma Pharmaceuticals has successfully completed a pre-investigational new drug (IND) application meeting with the U.S. Food and Drug Administration (FDA) for AT307, a ready-to-use injectable medicine. Hikma is the licensee of AT307, which was developed by Arecor.
Under the terms of their 2020 co-development and license agreement, Arecor is eligible to receive development milestone payments from Hikma, as well as future recurring revenue from royalty payments upon the commercialization of AT307.
Hikma has expressed its commitment to continuing the development of AT307 in the United States using the FDA regulatory pathway known as 505(b)(2). This pathway allows for a shorter regulatory review process when there is sufficient evidence of safety and clinical efficacy for a product that can be relied upon in new marketing applications.
"We are thrilled to receive this confirmatory news regarding Hikma's pursuit of an abbreviated 505(b)(2) approval pathway for AT307. This provides us with an opportunity to expedite the development and regulatory review process, ultimately making this medicine available to patients more quickly than through a traditional new drug approval route," stated Sarah Howell, the Chief Executive of Arecor.
All Rights Reserved © 2024
Post a comment