US reviews rare disorder with Roche, Novartis drugs

WASHINGTON, April 10 | Thu Apr 10, 2008 11:13am EDT

WASHINGTON, April 10 (Reuters) - U.S. health regulators are investigating whether two transplant drugs made by Roche Holding AG (ROG.VX) and Novartis AG (NOVN.VX) (NVS.N) could be linked to a rare central nervous system disorder, the U.S. Food and Drug Administration said on Thursday.

The two drugs, Roche's CellCept and Novartis' Myfortic, are used to prevent organ rejection. The FDA said it is reviewing whether they may trigger a potentially fatal disease called progressive multifocal leukoencephalopathy, or PML.

The FDA said Roche is aware of patients who have developed PML, and the company has given the agency related information as well as proposed updating prescribing information for the drug. The FDA said it has also asked Novartis for related data. (Reporting by Susan Heavey; editing by John Wallace)

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