US FDA approves Johnson & Johnson's novel AIDS drug Edurant; expands use of Pfizer's Sutent

The US Food and Drug Administration on Friday approved US health care giant Johnson & Johnson’s (NYSE: JNJ) Edurant (rilpivirine) tablets for use in combination with other antiretroviral agents (ARVs) in the treatment of human immunodeficiency virus type 1 (HIV-1) in adults who have never taken HIV therapy (treatment-naive).

Edurant, the first new AIDS drug in three years to gain FDA backing, was developed as TMC278 (rilpivirine) by J&J’s Ireland-based Tibotec Pharmaceuticals unit and is a non-nucleoside reverse transcriptase inhibitor, or NNRTI. In HIV treatment, NNRTIs are one class of the several types of ARVs that combat replication of the virus; NNRTIs block a specific protein that HIV-1 uses for replication. Edurant is the third anti-HIV medication to be commercialized in the USA by Tibotec.

“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,” said Edward Cox, Director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.