CytoDyn Completed Submission of All Remaining Parts of Biologics License Application (“BLA”) on May 11, 2020
CytoDyn Submits Requested Datasets to FDA for Biologics License Application
VANCOUVER, Washington, May 13, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today confirmed on May 11, 2020, it submitted all remaining parts of the Company’s Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients to the U.S. Food and Drug Administration (“FDA”). Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review.
As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision. After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA’s goal is to take action on the application within six months of receipt (compared with 10 months under standard review).
About Coronavirus Disease 2019
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.
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.