Gilead’s Long-Acting HIV Drug Among Latest EU Filings

The European Medicines Agency has added seven new products to its list of medicines that are under review for potential EU marketing authorization.

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The EMA has started reviewing a new batch of drug marketing applications • Source: Alamy

The European Medicines Agency has begun reviewing a number of new medicines for potential pan-EU marketing approval, including lenacapavir, Gilead Sciences’ investigational, first-in-class, long-acting viral capsid inhibitor for treating HIV in people with limited therapy options.

If authorized, lenacapavir would be the first capsid inhibitor and the only HIV treatment option administered twice yearly, claims Gilead, which in June filed a marketing application for the product in the US

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