Gilead's Lenacapavir Scores European Approval For Pretreated HIV Patients After Manufacturing Delays

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  • The European Commission has approved Gilead Sciences Inc’s GILD lenacapavir for adults with multi-drug resistant HIV infection. 
  • The drug, branded as Sunlenca on the continent, is designed to be administered once every six months.
  • “Lenacapavir is a unique and potent medicine with the potential for flexible dosing options,” CEO Dan O’Day said. “Following today’s approval, it will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV.”
  • Late last year, the FDA placed a hold on ten clinical trials after finding that the vials Gilead used to hold the drug could lead to an elevated risk of glass particulates seeping into the solution.
  • Soon after, the FDA followed up with a CRL citing the issues related to Gilead’s use of borosilicate glass. 
  • The FDA lifted the hold in May after Gilead switched to aluminosilicate glass. The biopharma followed that up with a resubmission to the FDA in July, with a PDUFA date of December 27.
  • Gilead had also signed a co-development pact to study lenacapavir in combination with Merck & Co Inc’s MRK islatravir. 
  • However, the latter drug is still on a clinical hold after Merck investigators flagged a drop in immune cell counts that an external committee determined was related to islatravir.
  • Price Action: GILD shares are down 0.92% at $64.74 on the last check Monday.
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