Second PrEP preventative HIV treatment approved by FDA

FDA Approves PrEP Drug

FDA Approves Second Drug To Be Used As PrEP: Descovy

It is only useful for the risk of HIV infection in men and transgender women who have sex with men.

DESCOVY for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex.

"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection", said Jeffrey Murray, M.D., deputy director of the Antiviral products division at the FDA.

According to the Centers for Disease Control and Prevention, 38,739 people received an HIV diagnosis in the U.S.in 2017.

FDA approval to prevent HIV for Descovy drug by Gilead may be a shot in the arm for it to compensate for its loss of Truvada sales in 2020.

The approval is part of long-term efforts to end the HIV epidemic by 2030.

Gilead has also been attacked by U.S. lawmakers for its pricing policy for Truvada, and responded by pledging enough of the drug to supply 200,000 patients annually for more than a decade.

It's a victory for Cuomo's "Ending the Epidemic" initiative, launched in 2014, which aimed to connect undiagnosed patients with proper care and prevent high-risk New Yorkers from contracting the virus, the governor's office said.

Descovy was already approved to be used as HIV treatment (in combination with other antiretroviral drugs) in 2016. Men who have sex with other men remain at a disproportionately high risk for contracting the virus, and most new cases are reported in the South, the fund reported.

In a statement, the FDA said that Descovy's efficacy in preventing HIV transmission was similar to Truvada (emtricitabine/tenofovir disoproxil fumarate), which became the first drug approved in the USA for PrEP in 2012, and has since grown into a $3bn product, with PrEP estimated to account for around $2bn of that total.

The primary endpoint was the rate of HIV-1 infection in each group. These data, which were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), included 5,387 individuals who were randomized 1:1 to receive either Descovy or Truvada.

Food and Drug Administration approves Gilead's Descovy as a preventive drug for HIV but not for vaginal infection: Food and Drug Administration, on 3rd October, approves Gilead's Descovy drug for HIV prevention. The FDA granted the approval of Descovy to Gilead Sciences Inc.

He added: "We see no reason to push back against commercial payers or Medicaid programmes that would move to prefer generic Truvada...provided there are guard-rails that do not deny access to Descovy for those who need Descovy". It is because the FDA has not evaluated the effectiveness of this significant population.

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