The European Unionʼs medicines regulator has recommended approval for Gilead Sciencesʼ Lenacapavir, a twice-yearly injection to prevent human immunodeficiency virus (HIV) in adults and adolescents.
Reuters writes about this.
Lenacapavir proved nearly 100 percent effective in preventing HIV in a large trial last year. The drug offers a long-term alternative to daily oral pills and other short-acting options. It is particularly important for those who struggle with daily adherence to treatment, stigma, or access to care.
The decision comes a little more than a month after the drug, which is marketed under the brand name Yeztugo, was approved by regulators in the United States. The World Health Organization recommended the treatment in early July as a means of preventing HIV infection.
Any recommendation for human medicines must be formally approved by the European Commission. It usually takes decisions based on the regulatorʼs recommendation. The European Commissionʼs decision is expected later this year.
- Lenacapavir is only the second long-term HIV prevention drug in the world. The first was Cabotegravir (brand name Apretude), which requires an injection every two months. It is manufactured by ViiV Healthcare, a subsidiary of British pharmaceutical giant GSK (GlaxoSmithKline).
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