FDA Clears New Johnson & Johnson HIV Drug
January 22, 2008
On Friday, the Food and Drug Administration approved Intelence (TMC125, etravirine) for use in combination with existing AIDS drugs in adult HIV patients who are failing other therapies. Made by Johnson & Johnson, Intelence is the newest approved drug in the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs), which block an enzyme HIV needs to replicate.
FDA approved the drug based on 24-week studies that showed 60 percent of patients who took an Intelence-based drug cocktail achieved an undetectable viral load. In comparison, 40 percent of patients taking a placebo in an AIDS drug combination attained undetectable levels of HIV.
Intelence can also be used in patients failing other NNRTIs, said Roger Pomerantz, president for research and development at Tibotec, a unit of Johnson & Johnson. "Doctors and patients can use [Intelence] in those patients that ... have had several or multiple rounds of resistance develop."
The new drug will have a wholesale cost of $5.45 per tablet, said Pamela Van Houten, a Tibotec spokesperson. The approved dosage is two tablets twice a day.
FDA said the most common side effects reported from the studies were skin rashes and nausea. In rare instances, serious rashes were noted; FDA advises patients on Intelence to tell their doctor if they develop rashes. Patients on the drug may develop infections, and the long-term effects of Intelence are not known, said FDA. Patients should also tell their doctor and pharmacist about all medications they take, as other drugs may interact with Intelence.
1.19.2008; Lisa Richwine
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