Delavirdine gets FDA approval
Delavirdine gets FDA approval
The Food and Drug Administration has approved delavirdine (Rescriptor) as a new non-nucleoside reverse transcriptase inhibitor to treat HIV infection in combination with other drugs.
The drug was studied in combination with several antiretroviral drugs in more than 2,400 patients since 1994. A drug interaction study also has been completed with the protease inhibitor indinavir.
"When used in combination, Rescriptor increased blood level of indinavir," says William Freimuth, MD, MPH, a clinical researcher for the drug’s manufacturer, Pharmaca & Upjohn in London.
The drug has been shown to be well-tolerated, with the main side effect being skin rash, which was observed in 18% of patients given the recommended dose of 400 mg three times a day.
The drug’s wholesale cost is $6.16 per day or $2,250 annually. The company will offer a minimum rebate of 15% to AIDS Drug Assistance Programs unable to purchase the drug at government-discounted prices.
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