Gilead’s Lenacapavir Tablet and Injection Products Prequalified by WHO
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 WHO. The products are prequalified via a new abridged prequalification pathway based on the positive scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) under the EU-M4all evaluation procedure. The total time to prequalifiction (including WHO’s and Applicant’s time) was just 36 days, counting from the date the application was accepted for assessment.
Lenacapavir is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing ≥35 kg who are at risk of HIV-1 acquisition.
In its recently issued HIV clinical guideline, WHO recommends offering long-acting injectable lenacapavir as an additional HIV prevention choice, as part of combination HIV prevention approaches (strong recommendation). It is an HIV-1 capsid inhibitor. Administered twice a year as PrEP, lenacapavir has been shown in two randomized, controlled clinical trials to be highly effective at reducing the risk of HIV acquisition. These products are also the first to be prequalified under WHO’s new pilot abridged prequalification procedure: Procedure to enable prequalification of products approved by Stringent Regulatory Authorities (SRAs) for use outside the SRA region (https://extranet.who.int/prequal/sites/default/files/document_files/Procedure%20to%20enable%20prequalification%20products%20approved%20by%20SRAs%20for%20use%20outside%20the%20SRA%20region-18%20March%202025_0.pdf )
Until recently, such products could only be included in the WHO prequalified products list using the SRA’s reference number based on the alternative listing procedure, which does not involve any abridged assessment by WHO Prequalification. The newly introduced procedure offers an alternative pathway, enabling WHO to conduct an abridged review of these products and prequalifying them with a full prequalification status and a WHO reference number.
Additionally, this new pathway can facilitate national registration through the Collaborative Registration Procedure for Prequalified Products (CRP-PQ), offering an alternative to the existing SRA-CRP mechanism. While the SRA-CRP mechanism involves sharing assessment reports from SRAs with NRAs in participating countries, the CRP-PQ pathway allows for the sharing of both SRA assessment reports and WHO’s abridged assessment reports with NRAs.