In August, the UK’s Medicines and Healthcare Regulatory Agency (MHRA) approved Sunlenca (lenacapavir) injection and tablets, alongside other antiretrovirals, in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Gilead Sciences’ (Nasdaq: GILD) therapy is a first-in-class capsid inhibitor with a multi-stage mechanism of action that 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.
The MHRA approval does not guarantee access to patients in the UK, however, with a positive recommendation from the National Institute for Health and Care Excellence (NICE) needed to ensure that Sunlenca is provided on the National Health Service (NHS).
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