The U.S. Food and Drug Administration is going to conduct some tests in order to find out if two transplant drugs have anything to do with a rare central nervous system disorder.
U.S. health regulators suspect Roche's CellCept and Novartis' Myfortic to cause progressive multifocal leukoencephalopathy (PML).
Both drugs are used to prevent rejection in organ transplantation. Its increasing application in treating lupus nephritis has demonstrated more frequent complete response and less frequent complications.
The FDA learned from Roche, a Swiss global health-care company, that there were 10 cases of patients who had developed PML. The complaints came from transplant patients as well as others with the autoimmune disorder lupus.
Now the fate of the drugs is in the FDA’s hands, while at least 500,000 patients worldwide can’t live without them.