FDAnews Drug Daily Bulletin

Johnson & Johnson (J&J) received FDA approval for its HIV combination therapy Intelence after the agency granted the drug accelerated review.

Intelence (etravirine) is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment-experienced adults with HIV resistance to other NNRTIs and antiretroviral agents, according to J&J.

Another combination therapy gaining agency approval is Novartis’ Tekturna HCT (aliskiren/hydrochlorothiazide [HCT]), a single-tablet combination of Tekturna and a diuretic for the treatment of high blood pressure.

Genentech received FDA approval for a supplement revising the indication for Herceptin (trastuzumab). The supplement revises the drug’s indication for use as a single agent for the adjuvant treatment of HER3-overexpressing node-negative or node-positive breast cancer following multimodality anthracycline-based therapy.

In another indication expansion, Abbott’s Humira (adalimumab) was approved by the FDA for the treatment of moderate to severe chronic plaque psoriasis.