Gilead announces CHMP opinion recommending lenacapavir

Gilead (GILD) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted an opinion under accelerated review recommending lenacapavir-the company’s injectable HIV-1 capsid inhibitor-for use as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union under the trade name Yeytuo. The marketing authorization application recommendation will now be reviewed by the EC as it evaluates lenacapavir as a potential new preventative strategy against HIV in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication. The CHMP also adopted a positive EU-Medicines for all opinion, which enables a streamlined assessment for World Health Organization prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries.