CytoDyn Files Request with FDA for Priority Review of BLA for First Approval of Leronlimab As Part of a Combination Therapy for HIV; If Granted, the FDA Is Expected to Take Action on the Company’s BLA Within Six Months

On June 1, 2020, CytoDyn, Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that it has filed with the U.S. Food and Drug Administration (FDA) a request seeking Priority Review designation for the company’s Biologics License Application (BLA) for leronlimab as part of a combination therapy for HIV indication. Under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times: Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). FDA informs the applicant of a Priority Review designation within 60 days. A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Significant improvement may be demonstrated by the following examples: evidence of increased effectiveness in treatment, prevention, or diagnosis of condition; elimination or substantial reduction of a treatment-limiting drug reaction; documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or evidence of safety and effectiveness in a new subpopulation.
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