FDA Approves New HIV Drug

The U.S. Food and Drug Administration on Friday approved a new HIV drug made by a unit of Johnson & Johnson.

The drug, Edurant, also known by its generic name rilpivirine, was approved for use in combination with other drugs in treating HIV patients who have not been previously treated with other HIV drugs.

Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor that work to block HIV viral replication.

"Patients may respond differently to various HIV drugs or experience varied side effects," said Edward Cox, director of the FDA's Office of Antimicrobial Products. "FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy."

The FDA said Edurant's approval was based on clinical studies that involved 1,368 adult patients with HIV infection. The studies compared Edurant to efavirenz, another HIV drug.

The study showed Edurant was as effective as efavirenz in lowering viral load, FDA said. Among patients receiving Edurant, 83 percent of them had an undetectable amount of HIV in their blood after 48 weeks of treatment compared to 80 percent of patients receiving efavirenz.

The most commonly reported side effects in patients taking Edurant included depression and difficulty sleeping, headache and rash.