U.S. probes Roche, Novartis drugs on rare disorder

By Susan Heavey

WASHINGTON (Reuters) - U.S. health regulators are investigating whether two transplant drugs made by Switzerland's 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 FDA said it is reviewing whether the two drugs -- Roche's CellCept and Novartis' Myfortic -- trigger a potentially fatal disease called progressive multifocal leukoencephalopathy, or PML. Both drugs are used to prevent organ rejection.

The FDA has received 16 reports of PML in CellCept patients since 1995, including some deaths, FDA spokesman Christopher Kelly said, adding that the agency is checking its databases to see if there were additional cases.

Roche spokesman Christopher Vancheri said it had 10 confirmed PML cases, and six cases of possible PML.

According to the FDA, Roche received the reports from transplant patients as well as others with the autoimmune disorder lupus -- although CellCept is not cleared for that condition. The company gave the data along with proposed new prescribing information for the drug to the FDA in November.

More than 500,000 patients worldwide have used CellCept, which brought in more than 2 billion Swiss francs (1 billion pounds) in 2007, according to the company.

CellCept, also known as mycophenolate mofetil, is approved to help prevent heart, liver and kidney transplant rejection, while Myfortic, or mycophenolic acid, is cleared to prevent kidney transplant rejection.

"Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic," the FDA said.