pharmaphorum October 3, 2024
Gilead Sciences has taken a major step towards increasing global access to HIV prevention with the signing of royalty-free voluntary licensing agreements with six generic manufacturers, paving the way for increased production and distribution of lenacapavir, its long-acting HIV prevention medication, in 120 high-incidence and resource-limited countries.
The announcement comes swiftly after the drug achieved significant milestones in two pivotal Phase 3 trials PURPOSE 1 and PURPOSE 2. Data from both studies showcased the superiority of twice-yearly injectable, lenacapavir, compared to once-daily oral Truvada and background HIV incidence rates, prompting Gilead to unblind the trials ahead of schedule, and begin the process of seeking regulatory approval for pre-exposure prophylaxis (PrEP).
If approved, the six manufacturers – Dr Reddy’s Laboratories Limited,...
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