Acasti Pharma Received Positive Feedback for CaPre From FDA

Acasti Pharma Inc. (CVE:APO) has received positive feedback from the US Food and Drug Administration on the proposed development pathway for CaPre.

“Recently, we received encouraging comments from the FDA based on our briefing package submission indicating that the 505(b)(2) pathway represents a course for regulatory review and approval, and that Acasti’s plans for the bioavailability bridging study are viewed as sound,” highlighted Pierre Lemieux, PhD, Acasti’s Chief Operating Officer. “With this endorsement, Acasti will submit an amendment to its current Investigational New Drug (IND) application to commence a bridging study, while continuing to work closely with the FDA to ensure the Corporation is aligned with their views on CaPretrademark clinical development.”
As previously announced, the 505(b)(2) approval pathway has been used by many other companies to secure approval for a New Drug Application (NDA). Acasti’s regulatory and clinical experts believe such a strategy is best for CaPretrademark. The 505(b)(2) application also enables regulatory submission for a New Chemical Entity (NCE) approval when some part of the data application is derived from studies not conducted by the applicant. It allows Acasti to further optimize the advancement of CaPretrademark, including the Phase 3 protocol design, while also benefiting from the substantial clinical and nonclinical data already available with another FDA-approved omega-3 prescription drug. In addition, it should reduce expenses, accelerate the timing and streamline the overall development program required to support a NDA submission. Based on the proposed 505(b)(2) regulatory pathway, Acasti is pursuing a pivotal bioavailability bridging study, comparing CaPretrademark and another FDA-approved omega-3 prescription drug as a means of establishing a scientific bridge between the two. This will help determine the feasibility of a 505(b)(2) regulatory pathway, while also optimizing the protocol design of a Phase 3 trial.505(b)(2) Regulatory Pathway.

Click here to read the full press release.