- For immediate release:
Today, the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral drug for adult patients with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other therapies. available due to resistance. or zero tolerance or safety considerations. After the starting dose is complete, Sunlenca is given as a subcutaneous (under the skin) injection once every six months, allowing appropriate dosing for patients.
“Today’s approval heralds 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. “The availability of new classes of antiretroviral drugs may help these patients live longer, healthier lives.”
Sunlenca is the first of a new class of drugs called capsid inhibitors that has been approved by the FDA for the treatment of HIV-1. Sunlenca works by blocking HIV-1’s protein envelope (capsid), thus interfering with several essential steps of the virus’s life cycle. The starting dose of Sunlenca is given as oral tablets and subcutaneous injection, followed by maintenance injections every six months; Sunlenca is given in combination with other antiretrovirals.
The safety and efficacy of Sunlenca was demonstrated in a multicenter clinical trial with 72 patients whose HIV infections were resistant to multiple classes of HIV drugs. These patients had to have high levels of the virus in their blood even though they were taking antiretroviral drugs. Patients were enrolled in one of the two study groups. One group was randomized to receive either Sunlenca or placebo in a double-blind manner, while the other group received an open label Sunlenca. The primary measure of effectiveness was the proportion of patients in the randomized study group who achieved some level of virus reduction within the first 14 days compared to baseline. In this group, 87.5% of patients who received Sunlenca achieved such a reduction in viral load compared to 16.7% of patients given placebo. After 26 weeks of using Sunlenca plus other antiretroviral drugs, 81% of participants in the first group achieved suppression of HIV RNA, where HIV levels were low enough to be considered undetectable. After 52 weeks, 83% of the participants continued to have HIV-suppressing RNA.
The most common adverse reactions reported with Sunlenca were injection site reactions and nausea. Most injection site reactions have been described as swelling, pain, or redness. Sunlenca comes with some warnings and precautions. Injection site reactions described as nodules or ulcers may be persistent in some patients. Additional warnings and precautions include the risk of immune reconstitution syndrome, which occurs when the immune system overreacts after starting HIV treatment. Also, small (residual) amounts of Sunlenca can stay in the body for up to a year or longer; Low drug levels resulting from missing doses of Sunlenca or failure to maintain a fully suppressive HIV treatment regimen after stopping Sunlenca may increase the risk of developing viral resistance. Residual amounts of Sunlenca can also lead to potential drug interactions.
Patients should not receive Sunlenca if they are also taking certain medications that cause low levels of Sunlenca. This may lead to loss of viral response and development of viral resistance.
The Food and Drug Administration (FDA) has granted Sunlenca Priority Review, Fast Track, and Breakthrough Therapy designations for this indication.
The US Food and Drug Administration (FDA) has granted Sunlenca approval to Gilead Sciences.
The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, and nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.
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