Gilead Sciences first won the approval of the FDA of a drug preparation for HIV twice a year

A drug on the sciences of Gilead which protects against HIV infection has won a highly anticipated approval of the FDA, becoming the first drug for the prevention of HIV available as an injection twice a year.

The regulatory decision announced Wednesday covers the use of antiviral drugs, Lenacapavir, for prophylaxis pre-exhibition in HIV-1 (PREP). Approval concerns adults and adolescents weighing at least 35 kg (around 77.1 pounds) who risk via HIV-1 sexually acquired. For this indication, Gilead will market the drug under the name of Yeztugo.

Gilead has experience with preparation drugs. The company’s truvada, approved in 2012, was the first preparation medication. Descovy, a Gilead preparation drug developed to cause fewer side effects, won its approval in 2019. Truvada and Descovy are formerly daily pills. Gilead cites the disease control and prevention centers showing 36% of people in the United States who are eligible for PREP have received a preparation medication. The factors contributing to the limited absorption of these drugs include difficulties in sticking to the drug diet or the stigma associated with these products. The administration twice a year of Yeztugo hoped to improve the adoption and membership of preparation.

“An injection twice a year could considerably approach key obstacles such as adhesion and stigma, which individuals on more frequent preparation dosage dosage, in particular daily oral preparation, can face,” said Dr. Carlos del Rio, professor of medicine at the Emory University School of Medicine and co-director of the Emory Center for Aids Research, in the announcement of Gilead. “We also know that, in research, many people who need or who want preparation preferred the less frequent dosage.”

The Lenacapavir is a small molecule designed to inhibit the capsid, the protein shell that surrounds the genetic material of a virus. This medication is a prolonged action of HIV-1 capsid inhibitor. It has been available in the United States since 2022, approved for the treatment of people whose HIV has become resistant to several drugs. In this indication, the medication Gilead is marketed under the Sunlenca brand.

The submission of Lenacapavir by Gilead for PREP was based on two clinical trials of phase 3 which compared the drug against Truvada or Descovy. The results of the two studies have shown that Yeztugo twice a year was greater than the prevention of HIV infections. The most common side effects in clinical trials were the reactions of the injection site, headache and nausea.

The Yeztugo label has a black box warning that it has the risk of resistance to medication in people infected with unmatched HIV-1. Due to this risk, a patient must be tested for HIV-1 before starting Yeztugo and with each subsequent dose of the drug. The label indicates that those who acquire HIV-1 upon receipt of Yeztugo must move on to a complete drug diet of HIV-1.

HIV is the largest therapeutic domain for Gilead, representing $ 19.6 billion in products in 2024, an increase of 8% compared to sales of the previous year. Descovy represented $ 2.1 billion in the total 2024 sales. The Truvada sales figures, which are now faced with generic competition, are no longer far from the company’s annual report.

Gilead has set an annual list of $ 28,218 for Yeztugo in the United States. Society has global ambitions for its new HIV drug. Regulatory submissions have been filed for Lenacapavir for preparation in Europe, Australia, Brazil, Canada and South Africa. Some countries depend on FDA approval for regulatory submission. Gilead said he had also made drug requests in these countries, notably Argentina, Mexico and Peru.

“This is a historic day in the fight of several decades against HIV,” said Gilead CEO Daniel O’Day, in a prepared statement. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help put an end to the HIV epidemic.”