US delays decision on first drug to prevent HIV

(AP) — Drugmaker Gilead Sciences Inc. says federal health regulators have delayed a decision on whether to approve its drug Truvada as the first pill that prevents HIV infection.

Gilead Sciences said Friday the Food and Administration will take an additional three months to review its drug application, after the California company submitted additional materials to the agency earlier this month.

In May, a panel of experts recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting . The group's vote is nonbinding, but the FDA often follows its advice.

Gilead says it submitted updated details on its safety materials for patients and doctors using Truvada. The FDA typically extends its reviews after receiving such information.

0 shares

Related Stories

AIDS fight enters new phase with prevention pill

date May 11, 2012

(AP) -- Condoms and other safe-sex practices have accomplished only so much. Now the 30-year battle against AIDS is on the verge of a radical new phase, with the government expected to endorse a once-a-day ...

AIDS drug trials may be virus stopper

date May 18, 2006

A U.S. pharmaceutical company is trying to get complete human data on a drug proven to prevent HIV in monkeys more than 12 years ago.

FDA panel backs first pill to block HIV infection

date May 11, 2012

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

Advocates: HIV prevention pill could save lives

date May 11, 2012

(AP) -- A pill to prevent HIV infection is already being given to some healthy people, but without government approval, it remains out of reach and too costly for many who need it.

Recommended for you

Rising antibiotic shortages raise concerns about patient care

date Apr 23, 2015

Shortages of key antibiotics, including gold-standard therapies and drugs used to treat highly resistant infections, are on the rise, according to a new study of shortages from 2001 to 2013 published in Clinical Infectious Di ...

Study supports HPV vaccination guidelines

date Apr 21, 2015

(HealthDay)—New research finds that young women who get the HPV vaccine gain significant protection against infection in three parts of the body if they haven't already been exposed to the human papillomavirus.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.