Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of lenacapavir’s marketing authorisation application (MAA) and EU-Medicines for all (EU-M4all) applications.
Lenacapavir is a twice-yearly injectable human immunodeficiency virus-1 (HIV-1) capsid inhibitor intended to prevent HIV as pre-exposure prophylaxis (PrEP).
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The latest announcement follows the recent US Food and Drug Administration (FDA) acceptance of the company’s new drug applications for lenacapavir for PrEP.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the MAA under the centralised licensing procedure for all 27 European Union member states, along with Iceland, Liechtenstein and Norway.
The EU-M4all application will also be reviewed, to secure a CHMP opinion that can be used by regulatory authorities beyond the EU, including in low- and lower-middle-income nations, to enable accelerated review processes in those countries and speed up the accessibility of lenacapavir for PrEP.
Gilead Sciences chief medical officer Dietmar Berger stated: “Achieving another key regulatory milestone so soon after the US FDA’s acceptance of our new drug applications for lenacapavir for PrEP underscores the great interest in how this medication, if approved, could help transform efforts to end the HIV epidemic globally.”
The current applications are backed by data from the company-conducted Phase III trials: PURPOSE 1 and PURPOSE 2.
In the PURPOSE 1 trial, Lenacapavir showed complete risk minimisation in HIV prevention among cisgender women, with zero infections.
In the PURPOSE 2 trial, lenacapavir showed a 96% risk minimisation in HIV infections among a diverse group of cisgender men and gender-diverse participants, with only two infections reported.
Both trials indicated that the therapy was superior to oral, once-a-day Truvada for the prevention of HIV infections and was well-tolerated, with no new safety concerns.
Lenacapavir gained approval in several nations for treating the adult population with multi-drug resistant HIV in conjunction with other antiretrovirals.
