CytoDyn Receives BLA Acknowledgment Letter from FDA; PDUFA Date Could Be Set by FDA on July 10

On June 8, 2020, CytoDyn, Inc., a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the U.S. Food and Drug Administration (FDA) has advised the Company, subject to its ongoing review, that it could receive its “PDUFA date” on July 10, 2020. Under the Prescription Drug User Fee Act (PDUFA), the FDA sets a goal date for the agency to complete its review of a new drug application; this date is commonly referred to as the “PDUFA date.” The FDA’s standard review time for new drug applications is 10 months. CytoDyn’s drug candidate, leronlimab, was previously granted Fast Track designation by the FDA and the Biologics License Application (BLA) was granted rolling review. The Company recently filed for Priority Review designation with the intent to reduce the FDA’s review time to six months. The FDA informs the applicant of a Priority Review designation within 60 days. Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, commented, “We are very encouraged by our recent correspondence with the FDA and remain hopeful of a PDUFA date to be announced by the agency on July 10. The review of our BLA could not be more timely, as our other trials for COVID-19 are approaching two important milestones and should the outcomes be successful, we believe the information in this BLA could be very useful in expediting approval of leronlimab to treat COVID-19, as well as HIV.” CytoDyn is currently enrolling patients in two clinical trials for COVID-19--a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S., and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
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