FDA declines approval for Rituxan, methotrexate combination

SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration declined to approve an additional use of a rheumatoid arthritis drug while approving an update to its prescribing information, the drug’s manufacturers announced Monday.

Roche subsidiary Genentech and Biogen Idec said the FDA had given them a complete response letter for their approval application seeking additional use of the drug Rituxan (rituximab), for combining Rituxan with the generic drug methotrexate in patients with moderate to severe rheumatoid arthritis who no longer respond to treatment with disease-modifying antirheumatic drugs such as methotrexate alone.

At the same time, the FDA approved an update to Rituxan’s labeling to show how late-stage rheumatoid arthritis patients can be treated again with Rituxan if they have not responded well enough to drugs called  tumor necrosis factor-antagonist therapies.

The FDA declined the approval application for Rituxan combined with methotrexate due to the rare risk of patients developing progressive multifocal leukoencephalopathy, a usually deadly brain infection caused by the JC virus. PML is rare in patients taking Rituxan, but Genentech also withdrew the psoriasis drug Raptiva (efalizumab) earlier this year after determining that the benefits of the drug did not outweigh the risks of patients developing PML.