Gilead Sciences Gets CRL From FDA For Investigational Lenacapavir Due To Vial Compatability Issues

Gilead Sciences Inc. (GILD) said it has received a complete response letter from the U.S. Food and Drug Administration for Investigational Lenacapavir, citing issues related to compatibility of vials and lenacapavir solution. The FDA did not ask new clinical studies in the CRL.

Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

Gilead plans to provide FDA with a comprehensive plan and corresponding data to use a different vial type.

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