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Tracking Global Approvals

Lenacapavir (LEN) has been reviewed under the “EU Medicines for All” (M4ALL) process and WHO’s Collaborative Registration Procedure (CRP) in order to help national regulators in LMICs accelerate their reviews. This has significantly shortened review time compared to previous PrEP products.

Faster Rollout for LEN

The timeline for hitting key milestones in product introduction is moving faster for injectable LEN than for any previous PrEP products, starting from the announcement of efficacy results in Phase III trials. LEN’s accelerated timeline compared to oral PrEP, DVR, and CAB reflects a field-wide effort to learn lessons from previous PrEP rollout and not repeat the mistakes of the past.

Choice Counselling: A conversation that centres the wants and needs of potential PrEP users

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