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

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.

Non-psychotropic cannabinoids show promise for pain relief

September 4, 2017
Some cancers love bone. They thrive in its nutrient-rich environment while gnawing away at the very substrate that sustains them, all the while releasing inflammatory substances that cause pain—pain so severe that opioids ...

Fentanyl drives rise in opioid-linked deaths in U.S.

August 31, 2017
(HealthDay)—Fentanyl, a synthetic narcotic, is a key player in America's continuing epidemic of opioid-related overdose deaths, two new studies report.

Eating triggers endorphin release in the brain

August 28, 2017
Finnish researchers have revealed how eating stimulates brain's endogenous opioid system to signal pleasure and satiety.

Cholesterol-lowering drugs may fight infectious disease

August 21, 2017
That statin you've been taking to lower your risk of heart attack or stroke may one day pull double duty, providing protection against a whole host of infectious diseases, including typhoid fever, chlamydia, and malaria.

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

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.