FDA Approves Antiretroviral Drug Combination of Roche’s Invirase, Abbott’s Norvir

Swiss drug maker Roche on Tuesday announced that the FDA has approved the company's protease inhibitor Invirase for use in combination with Abbott Laboratories' Norvir -- which is known generically as ritonavir -- for the treatment of HIV, Reuters reports. In research studies, Roche found that 1,000 mg of Invirase used in combination with 100 mg of Norvir boosted the level of Invirase in a patient's bloodstream compared with using Invirase alone (Reuters, 1/6). Roche also found that using 1,000 mg of Invirase and 100 mg of Norvir together produced similar results to using 1,200 mg of Roche's antiretroviral drug Fortovase with 100 mg of Norvir. However, using Invirase instead of Fortovase cuts dosage from three times a day to twice a day. In addition, Invirase does not require refrigeration and produces fewer gastrointestinal side effects than Fortovase (Dow Jones News Service, 1/6). Roche is currently developing a 500 mg formulation of Invirase and expects to submit it for FDA review in 2004, the company said (AFX News, 1/7).