Posts
On Friday, Johnson & Johnson’s new HIV drug Edurant (rilpivirine) gained approval from the Food and Drug Administration. Taken once a day, Edurant is approved for use in combination with other antiretroviral drugs for treatment-naïve HIV patients, FDA said. The non-nucleoside reverse transcriptase inhibitor, made by J&J’s Tibotec Pharmaceuticals unit in Ireland, is the first new HIV treatment licensed in three years.In trials, Edurant was as effective as Sustiva (efavirenz) in lowering viral load when given in combination with other antiretroviral drugs. J&J will sell Edurant as a stand-alone pill for use in combination therapies, and it also has a planned combination pill with Gilead Science’s Truvada, which may be approved by FDA in August, Gilead COO John Milligan told investors this month.
"Patients may respond differently to various HIV drugs or experience varied side effects,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “FDA’s approval of Edurant provides additional treatment options for patients who are starting HIV therapy.”
In a study released in July 2010, 9 percent of patients taking Edurant developed resistance, compared with 5 percent for efavirenz. “In the grand scheme of things, 9 percent is still pretty low,” said Courtney Stanton, an analyst with Decision Resources Inc.
The most commonly reported side effects in those taking Edurant included depression, insomnia, headache, and rash. Fewer discontinued Edurant than efavirenz due to side effects, FDA said.
For more information, visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256087.htm.
The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
