Gilead Sciences Inc., the California drug maker with Branford operations, received a positive endorsement Thursday from a panel of FDA advisors for one of its HIV treatments and will likely receive another good review Friday, The Associated Press reports, citing analysts.
A Food and Drug Administration panel recommended approval of the daily pill Truvada for use in preventing HIV infection. The recommendation is for healthy people who are at high risk of contracting HIV. The FDA, which usually follows the panel's advice, is expected to make a final decision next month.
Gilead, based in Foster City, Calif., has marketed the drug since 2004 as a treatment for people already infected with the virus that causes AIDS. Doctors usually prescribe it as part of a drug cocktail to repress the virus.
Because Truvada is already on the market for this, some doctors also prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.
On Friday, an FDA advisory panel will review the effectiveness and safety of Gilead's "Quad" pill, an HIV and AIDS treatment that combines four different medications. Analysts have said this potential drug is key to Gilead extending the line of treatments it has for HIV.
Safety questions for the panel's review will focus on potential kidney issues, but Stifel Nicolaus analyst Joel Sendek said in a research note he doesn't anticipate any significant concerns. He wrote that data from two late-stage clinical studies overwhelmingly supports approval.
An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to breakdown, leading to infections which are eventually fatal.
Gilead shares rose $1.47, or 2.9 percent, to $52.75 in premarket trading Friday.