Gilead's Descovy HIV combination approved in US
The US Food and Drug administration has approved Gilead's Descovy (emtricitabine+tenofovir alafenamide) HIV fixed-dose combination, a drug tipped to generate annual sales of more than $2 billion.
Descovy, which was recommended by Europe's CHMP in February, has a similar action to Gilead's older Truvada (emtricitabine+tenofovir disoproxil fumarate).
But the new salt allows a lower 25mg dose of tenofovir compared with Truvada, which has a 200mg dose. The new combination has shown an improvement in renal and bone safety in combination with other antiretroviral agents.
Descovy is indicated in combination with other antiretroviral agents for treatment of HIV-1 infection in adults and children 12 years of age and older.
Unlike Truvada, Descovy is not indicated in the US for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
In a report on blockbusters about to enter the market, Thomson Reuters forecast annual sales of just over $2 billion in 2020 for Descovy.
The FDA approved Odefsey, which adds Janssen's rilpivirine to the Descovy combination at the beginning of March. Thomson Reuters predicted this combination would generate almost $1.6 billion in sales by 2020.
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