Gilead Sciences (GILD) said Monday its two applications for lenacapavir as a pre-exposure prophylaxis to prevent HIV have been validated for parallel accelerated review by the European Medicines Agency.
The company said one application is for a marketing authorization and another is an EU-Medicines for all, or EU-M4all, application to facilitate expedited review processes for the injectable HIV-1 capsid inhibitor in other countries outside the EU.
Both applications are supported by phase 3 data that showed twice-yearly lenacapavir achieved risk reduction in HIV infections of 96% to 100%, the company added.
Gilead Sciences said the EMA validation followed the acceptance by the US Food and Drug Administration of its new drug applications for lenacapavir.
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