CytoDyn Inc (OTCQB:CYDY) has announced plans to submit additional clinical datasets to the US Food and Drug Administration (FDA) related to its drug leronlimab as a combination therapy with HAART for HIV patients.
The company filed a Biologics License Application (BLA) to the FDA on April 27, but the agency determined that the process would not be complete without additional datasets to address feedback the company from the regulator received in March.
Once the BLA submission is deemed complete, the FDA will make a decision on the drug’s filing and set a deadline date for drug review.
READ: CytoDyn says Novant Health initiates Phase 2b/3 trial with leronlimab for critically ill coronavirus patients
CytoDyn has been granted Fast Track designation for leronlimab and a rolling review for its BLA, and the company said it plans to request a priority review designation for its BLA. If granted, such a designation would mean the FDA’s goal is to take action within 6 months, as opposed to the normal 10 months.
In addition to its use as part of a combination therapy for HIV, leronlimab has also been granted Fast Track designation for the treatment of metastatic triple-negative breast cancer.
Separately, CytoDyn is currently enrolling patients in two clinical trials using leronlimab for coronavirus (COVID-19): a Phase 2 randomized trial for mild-to-moderate coronavirus patients and a Phase 2b/3 randomized trial of severely ill coronavirus patients.
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Published at Mon, 11 May 2020 12:45:00 +0000-CytoDyn to submit additional leronlimab documents to FDA for Biologics License Application