Friday, May 20, 2011

U.S. FDA approves J&J HIV drug for combination use

Fri May 20, 2011 11:48am EDT
* Edurant approved for previously untreated patients
* Must be used as part of antiretroviral regimen
NEW YORK May 20 (Reuters) - A Johnson & Johnson (JNJ.N) HIV drug won U.S. approval for use in combination with other drugs in patients who have not received prior treatment for the virus that causes AIDS, the Food and Drug Administration said on Friday.
The drug, a once-a-day pill to be sold under the brand name Edurant, works by blocking viral replication and was approved to be taken as part of an antiretroviral therapy regimen designed to suppress the amount of HIV in the blood.
Edurant, known chemically as rilpivirine, is likely to be used in combination with HIV drugs sold by Gilead Sciences Inc (GILD.O).
"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," Edward Cox, director of the FDA's Office of Antimicrobial Products, said in a statement.
Edurant was approved based on clinical trials in which it was shown to be as effective in lowering viral load as Bristol-Myers Squibb's (BMY.N) HIV drug Sustiva, the agency said.
The most commonly reported side effects seen with Edurant in clinical trials included depression, insomnia, headache and rash. (Reporting by Bill Berkrot. Editing by Robert MacMillan)

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