Gilead Hit By FDA Complete Response Letter For Lenacapavir In HIV Infection

 

• The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's 
  GILD -0.23%
   (Get Free Alerts for GILD) application for lenacapavir for heavily treated multi-drug resistant (MDR) HIV-1 infection.
• Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor.
• In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial. 
• The FDA raised questions about vials made of borosilicate glass and their compatibility with the lenacapavir solution, resulting in a clinical hold for injectable lenacapavir.
• Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type.
• The lenacapavir application was submitted to the FDA to treat heavily-treatment experienced people with multi-drug resistant HIV in June 2021 and selected for priority review. 

https://www.benzinga.com/general/biotech/22/03/25908224/gilead-hit-by-fda-complete-response-letter-for-lenacapavir-in-hiv-infection