Shots:
- The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027)
- sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse people
- Lenacapavir oral tablets are approved as part of the Yeztugo regimen for use as an initial loading dose & as a bridge therapy when scheduled once-every-six-month injections are delayed
Ref: Businesswire | Image: Gilead | Press Release
Related News: Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)
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