The European Union’s drugs regulator has recommended approval of Gilead Sciences’ (GILD.O), opens new tab lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents, the drugmaker said on Friday.
The backing could make it the EU’s first twice-yearly HIV prevention option to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents.
Lenacapavir offers a long-acting alternative to daily oral pills and other shorter-acting options, aiding critical response to the disease especially among those who struggle with daily adherence, stigma, or access to healthcare.
The decision comes more than a month after the treatment received regulatory approval in the U.S., where it is branded as Yeztugo.
The World Health Organization recommended the treatment earlier this month as a tool to prevent HIV infection.
Any recommendation by the European Medicines Agency’s human medicines committee has to be formally approved by the European Commission, which usually follows the regulator’s decision.
The European Commission’s decision on the drug is expected later this year, the company said.
If approved,lenacapavir would be granted one additional year of market exclusivity in the EU, and it would be branded as Yeytuo, Gilead said.
Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year.
