*

Lenacapavir approved for PrEP in EU, Norway, Iceland,

Liechtenstein

*

Pricing, reimbursement to be determined with each country

*

Gilead's lenacapavir nearly 100% effective in trials

*

By Deena Beasley

Aug 26 (Reuters) - The European Commission has granted

marketing authorization for Gilead Sciences' ( GILD )

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.