Gilead Reports EMA’s Validation of MAA for Lenacapavir to Treat HIV-1 in People with Limited Therapy Options

August 20, 2021 Auto Bot EMA, Gilead, lenacapavir, MAA, regulatory 0

Shots:

  • The MAA is based on the ongoing P-II/III CAPELLA study evaluates the antiviral activity of lenacapavir (PO, SC, every 6mos.) in combination with other antiretroviral agents vs PBO in a ratio (2:1) in 36 patients with multi-drug resistant HIV-1 infection
  • Results: viral load reduction from baseline of at least 0.5 log10 copies/mL for 14-day functional monothx. period (88% vs 17%). The therapy was generally well-tolerated with no serious
  • The EMA’s CHMP will review the application under the centralized licensing procedure for all 27 member states of the EU, Norway, Iceland & Liechtenstein. If approved, Lenacapavir will be the 1st capsid inhibitor & only HIV-1 treatment option

Click here to­ read full press release/ article | Ref: Businesswire | Image: The Wire Science

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