Gilead Sciences, Inc. (GILD) announced the Committee for Medicinal Products for
Human Use of the European Medicines Agency adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral, in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The company said the positive opinion is supported by data from the phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study.
Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use.
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