trending Market Intelligence /marketintelligence/en/news-insights/trending/_IvSr3NGtJOxI4AKfINSYw2 content esgSubNav
In This List

Gilead's Descovy picks up US FDA approval for PrEP HIV prevention

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Gilead's Descovy picks up US FDA approval for PrEP HIV prevention

Gilead Sciences Inc.'s HIV drug Descovy has won U.S. Food and Drug Administration approval as a treatment to prevent sexually acquired HIV infections, making it the second approved pre-exposure prophylaxis, or PrEP, drug after the company's Truvada.

The U.S. regulatory agency approved the treatment for use in adults and adolescents who weigh at least 77 pounds, do not already have HIV and are at risk for sexual infection.

SNL Image

The drug was approved under the FDA's priority review designation and comes with warnings for patients who have been treated for hepatitis B and those with undiagnosed HIV.

Excluded from the indication were people at risk from receptive vaginal sex because the effectiveness had not been established in a late-stage study called Discover.

Discover, which included more than 5,300 men and transgender women who have sex with men, showed that Descovy worked as well as Truvada at preventing infections.

"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," Gilead CEO Daniel O'Day said in an Oct. 3 release.

Descovy was previously approved by the FDA in 2016 to treat patients already infected with HIV. The drug is used in combination with other antiretroviral therapies to treat the infection in adults and children.

About 1.7 million people worldwide became newly infected with HIV in 2018, according to the World Health Organization, and about 37.9 million people were living with HIV at the end of the year.

The WHO and the Centers for Disease Control and Prevention both recommend PrEP as a prevention strategy.

SVB Leerink analysts said in a note issued Oct. 3 that the exclusion of cisgender women from the approval was expected, given that an FDA advisory committee in August flagged concerns with the data in this population. Gilead has said women account for about 10% of patients using Truvada for PrEP, a market of 212,000 patients valued at $2.5 billion overall, Leerink said.

"This exclusion is likely to be only a minor disappointment to investors," the analysts said.

Gilead will now have a year to switch patients over to Descovy for PrEP before the patent expires on Truvada and generic competition begins to put pressure on sales, Leerink said. The firm expects Descovy sales to grow from $1.5 billion in 2019 to $3 billion in 2022. The drug will likely capture about 50% of Truvada's revenue.