The EU has approved an HIV vaccine.

On August 26, the European Commission (EC) approved the marketing of Gilead's (US) HIV vaccine Lenacapavir, allowing it to be available in 27 EU countries, along with Norway, Iceland, and Liechtenstein. However, the cost of receiving the injection is exorbitant.

Lenacapavir is an HIV vaccine.

According to Reuters, this two-dose-per-year injection will be sold in the European Union (EU) under the name Yeytuo, and is approved for use in 27 member states along with Norway, Iceland, and Liechtenstein.

The EC approved this drug as a pre-exposure prophylaxis (PrEP) treatment, aimed at reducing the risk of HIV infection through sexual contact in adults and adolescents at high risk of contracting this deadly virus.

Before the drugs reach patients, Gilead needs to finalize agreements on pricing and reimbursement mechanisms with the healthcare systems of each country.

Lenacapavir demonstrated nearly 100% effectiveness in preventing HIV in large-scale trials last year, raising new hopes of stopping the transmission of the virus that infects 1.3 million people annually.

Gilead said its application for a license in the EU market was processed according to a faster timeline and was granted an additional year of market protection.

The company also stated that it has applied for authorization for Lenacapavir with authorities in Australia, Brazil, Canada, South Africa, and Switzerland, and is preparing applications in Argentina, Mexico, and Peru.

Last July, the World Health Organization recommended Lenacapavir as an additional option for HIV prevention.

Previously, the US Food and Drug Administration (FDA) approved Lenacapavir under the name Yeztugo, with a list price of over $28,000 for a year's treatment, equivalent to two injections.

However, some insurance companies in the US are delaying payments for Yeztugo, citing its exorbitant price compared to generic drugs. Some analysts predict sales of the drug could reach over $4 billion annually by 2029.

Gilead has stated that it will pursue applications to regulatory authorities in low- and middle-income countries.

The company also plans to work with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide Lenacapavir to up to 2 million people in low-income countries over the next three years, according to Reuters.

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Source: https://baolaocai.vn/eu-da-cap-phep-cho-thuoc-tiem-phong-hiv-post880574.html