EU approves HIV vaccine

On August 26, the European Commission (EC) granted a marketing authorization for the HIV vaccine Lenacapavir from Gilead (USA), allowing it to be present in 27 EU countries, as well as Norway, Iceland and Liechtenstein. However, the cost of the injection is sky-high.

HIV vaccine Lenacapavir.

According to Reuters, this 2-dose/year injection will be sold in the European Union (EU) under the name Yeytuo, and is allowed to circulate in 27 member countries along with Norway, Iceland and Liechtenstein.

The EC approved the drug as pre-exposure prophylaxis (PrEP), to reduce the risk of sexually transmitted HIV infection in adults and adolescents at high risk of contracting the deadly virus.

Before the drug reaches patients, Gilead needs to finalize pricing and reimbursement agreements with each country's health care system.

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

Gilead said its application for EU market approval had been reviewed on an accelerated timetable, and was granted an additional year of market protection.

The company also said it has filed applications for Lenacapavir with regulators in Australia, Brazil, Canada, South Africa and Switzerland and is preparing applications in Argentina, Mexico and Peru.

The World Health Organization last July recommended Lenacapavir as an additional option for HIV prevention.

Previously, the US Food and Drug Administration (FDA) approved Lenacapavir under the brand name Yeztugo, with a listed price of more than $28,000 for a year of treatment, equivalent to two injections.

But some U.S. insurers are delaying coverage of Yeztugo, citing its exorbitant price compared to generics. Some analysts predict sales of the drug could reach more than $4 billion a year by 2029.

Gilead said it will pursue applications with regulators in low- and middle-income countries.

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

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