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FDA Approves Descovy, Second Drug To Prevent HIV Infection

fdaapprovesdescovy oct04 lt

The U.S. Food and Drug Administration approved Gilead Sciences' drug Descovy to reduce the risk of sexually acquired HIV infection in adults and adolescents who do not have HIV, but are exposed to risk. This is the second drug to be approved by the FDA to prevent HIV infection as part of its efforts to end the epidemic.

However, Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) is not yet indicated for certain groups, including use by women who have vaginal sex, to prevent HIV infection as its effectiveness in this population has not been evaluated.

The FDA said that Descovy for PrEP has been approved to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35kg who do not have HIV, but are vulneable to sexually acquired HIV.

PrEP, or pre-exposure prophylaxis, is an HIV prevention method in which people who are HIV-negative take the medicine on a daily basis to mitigate the risk of getting HIV if they are exposed to the virus.

The agency approved the supplemental New Drug Application or sNDA for Descovy under a priority review designation.

Descovy was approved by the FDA in 2016 in combination with other antiretoviral drugs to treat HIV-1 infection in adults and pediatric patients. Gilead's blockbuster HIV drug Truvada was approved as a daily pill for PrEP in 2012.

The approval of a PrEP indication for Descovy was based on data from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial.

The trial evaluated the safety and efficacy of Descovy compared with that of Truvada for PrEP in reducing the risk of acquiring HIV-1 infection. Descovy demonstrated non-inferior efficacy as well as an improved bone and renal safety profile compared with Truvada.

"Descovy for PrEP provides a new HIV prevention option that matches Truvada's high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time," said Daniel O'Day, Chairman and CEO of Gilead Sciences.

Descovy had brought in global annual sales of $1.58 billion in 2018, compared to $1.22 billion in 2017.

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