Gilead Sciences' Can Resume Injectable Lenacapavir Trial(s) For HIV Infection

  • The FDA has lifted the clinical hold placed on Gilead Sciences Inc's GILD Investigational New Drug Application to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis. 
  • The agency has removed the clinical hold after reviewing Gilead's comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.
  • Related: FDA Slaps Clinical Hold On Gilead's Injectable Lenacapavir In HIV Trials.
  • All activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP. 
  • Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible.
  • In May 2019, the FDA granted Breakthrough Therapy Designation to lenacapavir for HIV infection in heavily treatment-experienced patients with multi-drug resistance and other antiretroviral drugs. 
  • Lenacapavir recently received an FDA complete response letter for its marketing application in this population due to vial compatibility. 
  • Gilead is working with the FDA to discuss the next steps for the potential use of lenacapavir to treat HIV in this population. 
  • Price Action: GILD shares traded 0.92% higher at $62.81 on the last check Tuesday.
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