(Reuters) - The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc's GILD.O Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men.
The approval does not include use of the drug by women to prevent HIV infection.
Descovy, a combination drug, was approved in 2016 to treat people already infected with HIV. It contains a newer formulation of a drug used in Gilead’s older medication, Truvada, which has been used to treat people infected with HIV since 2004.
Truvada was also approved as a daily pill for pre-exposure prophylaxis, or PrEP, in 2012. Gilead has said it aims to transition PrEP use from Truvada to Descovy before the older drug loses patent protection, which is expected next year.
The company said on Thursday that its list price for both Truvada and Descovy is $1,758 per month.
The FDA-approved label for Descovy, while more limited than Truvada’s, “comes as expected,” RBC Capital Markets analyst Brian Abrahams said in a research note. “The key will be the extent to which Gilead can transition the market to branded Descovy ahead of Truvada’s genericization in around one year.”
Descovy was shown in clinical trials to be less toxic than Truvada to the kidneys and bones. But some AIDS advocacy groups question whether it makes sense to prioritize Descovy for PrEP close to the time that cheaper generic versions of Truvada are to become available.
Gilead said on Thursday it has several patient assistance programs in place to help people get access to Descovy.
U.S. Sales of Truvada, which reached $2.6 billion last year, are forecast to drop to $428 million by 2024, while sales of Descovy, which totaled $1.2 billion in 2018, are expected to rise to $2.9 billion in 2024, according to IBES data from Refinitiv.
The Centers for Disease Control and Prevention estimates that 1.1 million people in the United States could benefit from PrEP. High-risk populations include people having sex with someone who is infected with HIV or who share injection needle equipment. Gilead said 213,000 people were taking Truvada for HIV prevention in the second quarter of this year.
Additional reporting by Manas Mishra; Editing by Dan Grebler
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