US delays decision on first drug to prevent HIV

June 9, 2012

(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.

Explore further: FDA review favors first drug for HIV prevention (Update)

shares

Related Stories

FDA review favors first drug for HIV prevention (Update)

May 8, 2012
(AP) -- A pill that has long been used to treat HIV has moved one step closer to becoming the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

AIDS fight enters new phase with prevention pill

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 pill to prevent ...

FDA panel backs first pill to block HIV infection

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

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.

US health advisors mull AIDS prevention pill (Update)

May 10, 2012
US health advisers on Thursday urged regulators to approve Truvada, made by Gilead Sciences, as the first preventive pill against HIV/AIDS instead of just a treatment for infected people.

Recommended for you

Fighting opioid addiction in primary care—new study shows it's possible

October 18, 2017
For many of the 2 million Americans addicted to opioids, getting good treatment and getting off prescription painkillers or heroin may seem like a far-off dream.

With no morphine, 25 million die in pain each year: report

October 13, 2017
Every year, some 25 million people—one in ten of them children—die in serious pain that could have been alleviated with morphine at just a few cents per dose, researchers said Friday.

Study finds few restrictions on Rx opioids through Medicare

October 9, 2017
Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for ...

Nocebo effect: Does a drug's high price tag cause its own side effects?

October 5, 2017
Pricey drugs may make people more vulnerable to perceiving side effects, a new study suggests—and the phenomenon is not just "in their heads."

Pre-packaged brand version of compounded medication to prevent preterm births costs 5,000 percent more

October 2, 2017
Preventing a preterm birth could cost as little as $200 or as much as $20,000, depending on which one of two medications a doctor orders, according to a new analysis from Harvard Medical School.

Cancer drugs' high prices not justified by cost of development, study contends

September 12, 2017
(HealthDay)— Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs.

0 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.