The FDA granted Priority Review, Fast Track and Breakthrough Therapy designations for Sunlenca — the brand name of lenacapavir — to Gilead Sciences.
“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in an FDA release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives,” she said.
Included in a new class of drugs, Sunlenca is the first medication called a “capsid inhibitor.” It works by blocking the capsid, or protein shell, of the HIV-1 virus.
Starting doses are given through injections and oral tablets. Following the initial treatment, maintenance injections are recommended every six months. Additionally, Sunlenca should be prescribed in combination with other antiretroviral medications.
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