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Benzinga
Benzinga
Technology
Vandana Singh

SHOCKING: Gilead hit by fda complete response letter for lenacapavir in hiv infection - You Need To See This

  • The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's (NASDAQ: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.
  • Related: Gilead's Lenacapavir Shows Sustained Efficacy In Pretreated HIV Patients.
  • 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. 
  • Price Action: GILD shares are down 0.66% at $60.00 during the market session on the last check Tuesday.
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