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CytoDyn's Leronlimab Suffers Refuse To File Letter; US FDA Concerned About Dosing, Manufacturing

 
• By Jessica Merrill

US FDA declines to review the CCR5 antagonist for use in highly treatment-experienced HIV patients. Safety data from an ongoing study should be sufficient to address the agency’s concerns about the higher 700mg dose, CytoDyn management says, but FDA also has questions about the production of the self-injectable syringes.

Stop sign
A refuse to file letter has stopped review of leronlimab by the US FDA until CytoDyn can provide more data.

CytoDyn, Inc. is pushing to develop the CCR5 antagonist leronlimab for a wide range of indications, including HIV, cancer and COVID-19, but the effort has hit a roadblock at the US Food and Drug Administration. The company announced on 13 July that it has received a refusal to file letter from the FDA for its first biologics license application for leronlimab for highly treatment experienced HIV patients.

The update casts more doubts on CytoDyn's development plan for leronlimab, which has already faced some stumbling blocks. The company said it filed the BLA on 27 April, but the...

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