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Gilead Gets Lenacapavir To EU Approval For HIV Salvage Therapy, Awaits FDA’s Call

 
• By Joseph Haas

A first-in-class capsid inhibitor, lenacapavir is a linchpin of Gilead’s long-term strategy in HIV treatment and prevention, but has faced regulatory setbacks in the US.

Gilead HQ
Gilead gets first of what it hopes will be many lenacapavir approvals • Source: Shutterstock: Sundry Photography

Gilead Sciences, Inc. has endured some setbacks in bringing its first-in-class capsid inhibitor lenacapavir to the finish line, but with a marketing authorization from the European Medicines Agency on 19 August the biopharma may be on the way to realizing its broad ambitions for the long-acting oral or injectable drug. Branded as Sunlenca, the drug’s initial approval is as part of combination therapy in multi-drug-resistant HIV patients who cannot achieve viral suppression with another regimen.

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