AIDS drug Intelence approved by FDA

23 January, 2007

A new AIDS-fighting drug has won US FDA approval paving the way for yet another path breaking medical discovery. Health-care company Johnson & Johnson’s new HIV drug called Intelence is aimed at AIDS patients with resistance to other therapies.

The news has come as a boon to as many as 40 million people who are infected with HIV. The new member of the anti-AIDS drug lot, which is also called the TMC125 or etravirine, belongs to the non-nucleoside reverse transcriptase inhibitors (NNRTI), said a report. US officials have said that at least 24 drugs have been approved for fighting the deadly HIV virus and that patients need new options because HIV can mutate to resist existing treatments. NNRTIs block a key enzyme that HIV uses to replicate, it has been found.

The FDI has approved Intelence for use with other AIDS drugs and has been cleared Intelence for adults for whom alternative HIV therapies have failed. According to medical experts such as Tibotec Research and Development president Roger Pomerantz, Intelence can be used in patients who have developed several or multiple rounds of resistance. Intelence will be available for a wholesale cost of $5.45 per tablet. As per the US FDA approval note, the dosage would be two tablets twice per day, or a total of four tablets daily.

The US FDA approval of Intelence has come as a result of studies based on patients who were administered treated with a cocktail of AIDS drugs plus Intelence or a placebo for 24 weeks. Sixty percent of patients treated with Intelence had their virus suppressed to undetectable levels, compared with 40 percent of placebo patients.

According to the FDA the most common side effects reported were skin rashes and nausea and so patients who take Intelence have been advised to seek medical advice in case a rash develops. AIDS drugs do not cure the infection but they can suppress the virus and minimize symptoms. The US FDA has also said that those patience who take Intelence are likely to develop infections.