Gilead Sciences gets Sunlenca FDA approval for multi-drug resistant HIV

Sunlenca FDA approval : Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of human immunodeficiency virus type 1 (HIV-1).

Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in adults having multidrug resistant HIV-1 infection.

According to Gilead Sciences, the multi-stage mechanism of action and the no cross resistance exhibited in vitro by Sunlenca provides twice-yearly treatment option for adults with HIV.

Daniel O’Day — Gilead Sciences Chairman and CEO, commenting on Sunlenca FDA approval, said: “This news is an important milestone in the work to help end the HIV epidemic as Sunlenca is now the only FDA-approved twice-yearly treatment for people with multi-drug resistant HIV who are heavily treatment experienced.

“Gilead scientists have developed a unique and potent antiretroviral medicine in Sunlenca with the potential for flexible dosing options.

“Our goal is to deliver multiple long-acting options for treatment and prevention that are tailored to the needs of people living with HIV and people who could benefit from PrEP medicines.”

Gilead Sciences gets Sunlenca FDA approval for multi-drug resistant HIV. Photo courtesy of Business Wire.

Sunlenca is administered as under the skin injection once every six months, following the completion of the starting dose.

Sunlenca FDA approval was backed by the results of the CAPELLA phase 2/3 clinical trial that demonstrated the safety and efficacy of the HIV-1 capsid inhibitor in combination with other antiretroviral in people with multi-drug resistant HIV-1 who are heavily treatment experienced.

In May 2019, Sunlenca received breakthrough therapy designation from the FDA for the development of the drug in combination with other antiretrovirals for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance.

Sunlenca, provided as a 300 mg tablet and as a 463.5 mg/1.5 mL injection for HIV prevention, is for investigational use only.

Lenacapavir, alone or in combination, is not approved by any regulatory authority outside of the US, UK, Canada, or the European Union for any indication.