Gilead Sciences receives FDA approval for two HIV preparatory medicines for the first time
A Gilead Sciences drug that prevents HIV infection has won the highly anticipated FDA approval as a twice-annual HIV prevention drug.
Regulatory decisions announced on Wednesday the use of the antiviral drug Lenacapavir covers HIV-1 pre-preventive prevention (PREP). The approval is for adults and adolescents weighing at least 35 kg (approximately 77.1 lbs) with risk of sexually acquired HIV-1. To do this, Gilead will sell the drug under the brand Yeztugo brand.
Gilead has experience in preparing medicines. The company's Truvada was approved in 2012 and is the first preparatory drug. Descovy is a Gilead Prep that developed fewer side effects and was approved in 2019. Truvada and Descovy are both pills once a day. Gilead cites the Centers for Disease Control and Prevention, showing that about 36% of people eligible for PREP prescribed medication. Factors that contribute to limited intake of these drugs include difficulty adhering to drug regimens or stigmas associated with these products. It is hoped that the management of Yeztugo twice a year will improve intake and compliance preparation.
“Twice injections per year can greatly address critical barriers such as compliance and stigma, especially daily oral preparation protocols, especially daily oral preparation,” said Dr. Carlos del Rio, professor of medicine at Emory University's School of Medicine and co-director of the Emory AIDS Research Center. “We also know that in studies, many people who need or want to prepare prefer less dosing.”
Lenacapavir is a small molecule designed to inhibit the cap shell of a protein shell that blocks the genetic material of the virus. This drug is a long-acting HIV-1 capsid inhibitor. It has been approved in the United States since 2022 for people who are resistant to multiple drugs. In this direction, Gilead drugs are sold under the brand Sunlenca.
Gilead submitted Lenacapavir for PREP submission based on two phase 3 clinical trials that compared the drug to Truvada or Descovy. Results from both studies show that Yeztugo performs excellently in preventing HIV infection twice a year. The most common adverse reactions reported in clinical trials are injection site reactions, headaches and nausea.
Yeztugo's tag carries a black box warning that the tag is at risk of drug resistance in undiagnosed patients with HIV-1 infection. Due to this risk, HIV-1 testing of patients must be performed before starting Yeztugo and all subsequent medications. The tag states that people who receive HIV-1 when receiving Yeztugo must transition to a complete HIV-1 drug regimen.
HIV is Gilead's largest therapeutic area, accounting for $19.6 billion in product revenue in 2024, an increase of 8% from sales in the previous year. Descovy accounts for $2.1 billion of total sales in 2024. Truvada's sales figures, now facing general competition, are no longer removed in the company's annual report.
Gilead, whose annual price tag for Yeztugo in the U.S. is $28,218, has global ambitions for its latest HIV drug. Submissions of regulatory submissions have been submitted to Lenacapavir in Europe, Australia, Brazil, Canada and South Africa. Some countries rely on FDA approval for regulatory submissions. Gilead said it has also filed applications for the drug in such countries, including Argentina, Mexico and Peru.
“This is a long history with HIV,” Gilead CEO Daniel O'Day said in a prepared statement. “Yeztugo is one of the most important scientific breakthroughs of our time and provides a very real opportunity to help end the HIV epidemic.”
