Milestone marks first lenacapavir-based product prequalified under WHO’s new abridged pathway, enabling faster access to innovative HIV prevention options worldwide.
By Bunmi Yekini
Gilead’s lenacapavir 300 mg tablets (HA810) and lenacapavir 463.5 mg/1.5 mL injection (HA811) have become the first lenacapavir-based products to be prequalified by the World Health Organization (WHO), marking a significant advancement in HIV prevention efforts.
The products were prequalified through WHO’s newly introduced abridged prequalification pathway, based on a positive scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) under the EU-M4all procedure. Impressively, the total prequalification process, including WHO and applicant time, was completed in just 36 days from acceptance for assessment.
Lenacapavir, an HIV-1 capsid inhibitor, is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk of infection. Administered twice a year, lenacapavir has shown high efficacy in reducing HIV acquisition in two randomized controlled clinical trials.
WHO’s latest HIV clinical guideline strongly recommends long-acting injectable lenacapavir as an additional prevention option, reinforcing its role in combination HIV prevention strategies.
These products are also the first to be prequalified under WHO’s new pilot abridged prequalification procedure, which enables prequalification of products approved by Stringent Regulatory Authorities (SRAs) for use outside their regions.
Previously, products could only be listed through WHO’s alternative listing procedure, which did not involve an abridged assessment. The new mechanism allows WHO to conduct a streamlined review and grant full prequalification status with a WHO reference number.
In addition, the new pathway supports national registration through the Collaborative Registration Procedure for Prequalified Products (CRP-PQ), facilitating quicker access in low- and middle-income countries by allowing the sharing of both SRA and WHO assessment reports with national regulatory authorities.