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CytoDyn Reports the Withdrawal of BLA for Leronlimab to Treat HIV

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CytoDyn Reports the Withdrawal of BLA for Leronlimab to Treat HIV

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  • The company reported the voluntarily withdrawn of BLA for leronlimab as a combination therapy due to CRO data management issues in patients with HIV with resistance to HAART in HIV-MDR
  • The withdrawal was based on multiple factors, incl. systemic issues with the quality of data collection & monitoring of pivotal clinical trials by the CRO to manage the trials which raised serious concerns about obtaining FDA BLA approval
  • The company will publish the results of the P-IIb/III trial for the HIV-MDR population shortly in a peer-reviewed journal. The company also submitted its responses to the US FDA for the clinical hold removal & continues to study leronlimab in other HIV-related, NASH & oncology indications

Ref: Globenewswire | Image: CytoDyn

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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