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Gilead's Descovy HIV Regimen Gets FDA Nod for Label Expansion
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Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA approved a label expansion of HIV treatment Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) as a prevention option.
The agency approved the treatment for a pre-exposure prophylaxis (PrEP) indication. Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg, who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.
The FDA approved Gilead’s supplemental New Drug Application (sNDA) for Descovy under a Priority Review designation.
The regimen was approved in the United States in 2016 for the treatment of HIV-1 infection in combination with other antiretroviral agents.
Importantly, Descovy for PrEP indication provides a new HIV prevention option that matches Gilead’s other HIV drug Truvada’s high efficacy with statistically significant improvements in renal and bone safety. We note that bone injuries and renal damages have been associated with some HIV treatments and hence these are important considerations as people at risk increasingly use PrEP for longer periods.
The approval was based on encouraging data from the multi-year global phase III registrational study, DISCOVER, wherein Descovy demonstrated non-inferior efficacy and an improved bone and renal safety profile compared with Truvada in people at risk of sexually acquired HIV Infection.
However, the regimen carries a boxed warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. The label will also include a boxed warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection.
The label expansion will strengthen Gilead’s industry-leading HIV portfolio. We note that the company has shifted focus to the HIV business lately as its HCV franchise continues to dwindle.
Gilead’s stock has lost 0.5% in the year so far compared with the industry's decline of 6.5%.
The rapid adoption of Biktarvy and Descovy-based regimens has maintained momentum for the company’s HIV franchise amid stiff competition from the likes of GlaxoSmithKline (GSK - Free Report) . Competition is also increasing from Merck (MRK - Free Report) , which gained FDA approval for the label expansion of its two HIV drugs — Pifeltro and Delstrigo.
Gilead is also looking to diversify its portfolio to reduce dependence on the HIV franchise and has collaborated with Novo Nordisk (NVO - Free Report) for NASH treatments.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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Gilead's Descovy HIV Regimen Gets FDA Nod for Label Expansion
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA approved a label expansion of HIV treatment Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) as a prevention option.
The agency approved the treatment for a pre-exposure prophylaxis (PrEP) indication. Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg, who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.
The FDA approved Gilead’s supplemental New Drug Application (sNDA) for Descovy under a Priority Review designation.
The regimen was approved in the United States in 2016 for the treatment of HIV-1 infection in combination with other antiretroviral agents.
Importantly, Descovy for PrEP indication provides a new HIV prevention option that matches Gilead’s other HIV drug Truvada’s high efficacy with statistically significant improvements in renal and bone safety. We note that bone injuries and renal damages have been associated with some HIV treatments and hence these are important considerations as people at risk increasingly use PrEP for longer periods.
The approval was based on encouraging data from the multi-year global phase III registrational study, DISCOVER, wherein Descovy demonstrated non-inferior efficacy and an improved bone and renal safety profile compared with Truvada in people at risk of sexually acquired HIV Infection.
However, the regimen carries a boxed warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. The label will also include a boxed warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection.
The label expansion will strengthen Gilead’s industry-leading HIV portfolio. We note that the company has shifted focus to the HIV business lately as its HCV franchise continues to dwindle.
Gilead’s stock has lost 0.5% in the year so far compared with the industry's decline of 6.5%.
The rapid adoption of Biktarvy and Descovy-based regimens has maintained momentum for the company’s HIV franchise amid stiff competition from the likes of GlaxoSmithKline (GSK - Free Report) . Competition is also increasing from Merck (MRK - Free Report) , which gained FDA approval for the label expansion of its two HIV drugs — Pifeltro and Delstrigo.
Gilead is also looking to diversify its portfolio to reduce dependence on the HIV franchise and has collaborated with Novo Nordisk (NVO - Free Report) for NASH treatments.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>