Johnson & Johnson's HIV drug Edurant has been approved by the US Food and Drug Administration.
The agency has given the green light for Edurant (rilpivirine) to be used in combination with other antiretrovirals in treatment-naive patients. The approval is based on two Phase III trials of the once-a-day pill, which is a non-nucleoside reverse transcriptase inhibitor, involving 1,368 adults.
Patients in the studies had not had prior HIV therapy and were selected to receive treatment with Edurant or Bristol-Myers Squibb's NNRTI Sustiva (efavirenz). The J&J drug was as effective as efavirenz in lowering viral load and among patients receiving the former, 83% had an undectable amount of HIV in their blood after 48 weeks of treatment compared to 80% of patients on Sustiva.
Edward Cox, the director of FDA's Office of Antimicrobial Products, said "patients may respond differently to various HIV drugs or experience varied side effects". As such, the approval of Edurant "provides an additional treatment option for patients who are starting HIV therapy".