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

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.