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MHRA grants marketing authorisation for treatment of HIV

Gilead Sciences have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sunlenca (lenacapavir) ® injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s) (NRTI, NNRTI, PI, INSTI1), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Lenacapavir is a first-in-class capsid inhibitor with a multi-stage mechanism of action and has no known cross resistance to other existing drug classes, offering a new, every six-month treatment option for eligible adults with HIV whose virus no longer effectively responds to their current therapy.

Despite the significant advances in ARV therapy, there remain numerous critical unmet needs for people with HIV. This is particularly true for people with HIV who are heavily treatment-experienced with limited therapy options and are unable to maintain virologic suppression due to resistance or challenges adhering to a complex regimen. This type of complexity further increases the chance of suboptimal adherence and treatment failure, underscoring the need for a new treatment option that is active against resistant variants of the virus with a novel mechanism of action.

Lenacapavir injection, in combination with other antiretroviral(s), is indicated in Great Britain for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Lenacapavir tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, for oral loading prior to administration of long-acting lenacapavir injection.

Véronique Walsh, General Manager at Gilead Sciences Ltd, said: “We are delighted that the MHRA has licensed lenacapavir for use in Great Britain – it will now be the first twice-yearly treatment for people who struggle with multi-drug resistant HIV.”

“At Gilead, we have a long-standing heritage in HIV, and we are committed to continuing to bring forward innovation with the aim to help end the HIV epidemic for everyone, everywhere.”

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