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Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment

On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market by the European Commission for adults living with multidrug-resistant HIV.


As a first-in-class capsid inhibitor with a multi-stage mechanism of action and no known cross-resistance to other drug classes, lanacapavir offers an alternative to the current treatment option for HIV patients whose virus no longer responds to their current treatment option every six months.

As a combination antiretroviral medication, Sunlenca is indicated for the treatment of adults with multidrug resistant HIV infection, for whom suppressive antiviral regimens are not otherwise possible. Lenacapavir tablets are approved for oral loading prior to administration of long-acting lenacapavir injection.


The marketing authorization applies to all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein. Sunlenca has only been approved for marketing in EU countries today, but the United States is likely to approve it soon.


In March, Gilead's NDA for Sunlenca was rejected by the FDA due to concerns about the drug's vials, but no concerns were raised about its effectiveness. A revised NDA was submitted in late June, with comprehensive data supporting the decision to use vials.


As of now, the regulatory body has accepted Sunlenca's application and will make a decision by December. If everything goes smoothly, Sunlenca could receive U.S. approval this year.


Click this LINK to know more about the Regulatory Approval of HIV Sunlenca® (Lenacapavir)




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