Sunlenca approved in Japan for the treatment of multi-drug-resistant HIV-1 infection
Gilead Sciences’ long-acting antiviral Sunlenca (lenacapavir) has secured Japanese regulatory approval for patients with multi-drug-resistant HIV and has obtained the approval for fast-track reimbursement listing, scheduled for August 9
The company won regulatory approval for the drug, a first-in-class capsid inhibitor for HIV treatment, on August 1, just a day after it was given the backing of the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Second Committee on Drugs. Then on August 2, the Central Social Insurance Medical Council, better known as Chuikyo, endorsed the NHI price listing of Sunlenca at its general meeting. The listing date was set for August 9.
Sunlenca is indicated for the treatment of multi-drug-resistant HIV-1 infection. It will be given twice yearly in combination with an optimized regimen for adults with multi-drug resistant HIV who have a history of multi-drug therapy and are unable to achieve adequate viral suppression with existing drugs. A reduction in the frequency of dosing will lead to a decrease in patient burdens.
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