Shares of healthcare group J&J were on the rise in after-hours trading over the weekend after US regulators gave the go-ahead to its new HIV therapy Intelence on Friday, offering thousands of patients who have become resistant to existing therapies a new option.

Intelence (etravirine), which was developed by J&J subsidiary Tibotec Therapeutics, is the first new member of the nucleoside reverse transcriptase inhibitor class of drugs to hit the market in almost a decade, after being granted accelerated approval by the US Food and Drug Administration for use alongside other antiretrovirals in the treatment of drug resistant patients with HIV type 1.

The green light was based on a pooled analysis of results from the DUET-1 and -2 studies, which showed that significantly more patients receiving Intelence had an undetectable viral load and a greater CD4+ cell count that those in the placebo arm at 24 weeks. But longer-term data will be necessary for the FDA to consider traditional approval, the company noted.

Unique benefit
The emergence of new weapons in the AIDS arsenal is crucial because HIV patients often develop resistance to their treatment and, importantly, Intelence is the first drug shown to be effective in those showing resistance to other therapies in the NRTI class.

According to Richard Haubrich, Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, and Intelence trial investigator: “Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV.”

Meanwhile, Johnson & Johnson said it will update the label for Ortho Evra (norelgestromin/ethinyl estradiol) to include data from a recent study which showed that patients using the contraceptive patch were more likely to develop venous thromboembolism compared to those taking oral contraceptives.