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LEDERLE RHEUMATREX (METHOTREXATE) FOR RHEUMOTOID ARTHRITIS

Executive Summary

LEDERLE RHEUMATREX (METHOTREXATE) FOR RHEUMOTOID ARTHRITIS will be launched in January in a "specially designed" dose pack. In a Nov. 1 press release announcing FDA approval of the new indication for the oral formulation of the anticancer drug, Lederle said it would be conducting a "comprehensive medical information program" prior to the launch to ensure appropriate use of the drug. FDA approved Lederle's methotrexate for use in treating severe, recalcitrant rheumatoid arthritis on Oct. 31. Lederle had applied for approval of the new indication over three years ago in a supplemental NDA submitted to the agency in June 1985. According to the approved labeling, Rheumatrex is indicated for the "management of selected adults with severe, active classical or definitive rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy, including full dose NSAIDS (nonsteroidal anti-inflammatory drugs) and usually a trial of at least one or more disease-modifying anti-rheumatic drugs." The off-patent drug will be marketed in a Rheumatrex Dose Pack to differentiate the Lederle product from generics. The Rheumatrex Dose Pack, Lederle said, is "designed to help patients safely comply with specific therapeutic regimen." The recommended dose for the rheumatoid indication is 7.5 mg once a week.

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