EU approves Gilead's new injection for preventing HIV

By Deena Beasley

(Reuters) -The European Commission has granted marketing authorization for Gilead Sciences' twice-yearly injection for preventing HIV infection, the company said on Tuesday.

The drug, known scientifically as lenacapavir, will be sold in Europe under the brand name Yeytuo. It was approved in June by regulators in the U.S., where it is marketed as Yeztugo.

The EC approval applies to use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein. Before the drug can be made available to patients, Gilead will need to establish pricing and reimbursement terms with health systems in each country.

In the United States, Gilead's list price for Yeztugo is over $28,000 a year. Some U.S. insurers are holding off on covering the new injection, citing its high price compared to generic pills.

Analysts project the drug will have sales of over $4 billion a year by 2029, according to LSEG.

The European Commission approved the drug for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV in adults and adolescents at increased risk of contracting the deadly virus.

Lenacapavir proved nearly 100% effective at preventing HIV in large trials last year, raising new hope of interrupting transmission of the virus that infects 1.3 million people a year.

Gilead said its EU application was reviewed under an accelerated timeline and was granted an additional year of market protection.

The company said it has also filed for regulatory review of twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada, South Africa and Switzerland and is preparing filings in Argentina, Mexico and Peru.

The World Health Organization in July recommended lenacapavir as an additional PrEP option for HIV prevention.

Gilead said it intends to pursue submissions to regulatory authorities in low- and middle-income countries including priority registrations covering 18 countries that represent 70% of the HIV burden of the 120 countries named in its previously announced voluntary licensing agreements.

The company plans, with the Global Fund to Fight AIDS, Tuberculosis and Malaria, to supply lenacapavir for up to two million people in low-income countries over three years as generic drugmakers gear up production under the royalty-free agreements.

(Reporting By Deena Beasley; Editing by Chris Reese)