The U.S. Food and Drug Administration approved the drug Sunlenca (lenacapavir), produced by Gilead Sciences, in combination with other antiretrovirals for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection.
Sunlenca offers a new, twice-yearly treatment option for HIV-positive adults that is not adequately controlled by their current regimen.
“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” Debra Birnkrant, M.D., said in a press release from the FDA. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”
Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, echoed the statement saying, “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.”
The approval for Sunlenca is supported by data from the Phase 2/3 CAPELLA trial. Participants had previously undergone previous treatment with a median of nine antiretroviral medications.
The review and approval for Sunlenca as a medication went through the FDA Breakthrough Therapy Designation intended to expedite the development and review of new drugs that may provide substantial improvement over available therapy.
The United States, United Kingdom, Canada and the European Union (EU) are the only countries to have approved the use of lenacapavir, whether alone or in combination. The European Marketing Authorization applies to all 27 member states of the EU, plus Norway, Iceland, and Liechtenstein.
More regulatory filings and decisions from regulatory authorities are anticipated to continue throughout 2023.