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US probes Roche, Novartis drugs on rare central nervous system disorder PML
  By Susan Heavey
WASHINGTON, April 10 (Reuters) - U.S. health regulators are investigating whether two transplant drugs made by Switzerland's Roche Holding AG and Novartis AG 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 ($1.99 billion U.S. dollars) in 2007, according to the company.
v 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.
"Decreasing total immunosuppression may improve the outcome of patients who develop PML," it added. FDA's Kelly said the discontinuation of the drugs is not necessarily recommended.
It will take two months to complete its review, the FDA said.
The agency already appears to be on track to require the two Swiss drugmakers to provide information about possible PML on the drug labels for CellCept and Myfortic. It could also decide to take further action, such as calling for new warning information on the packages or holding a public meeting.
Sales of a multiple sclerosis drug, Biogen Idec Inc's and Elan Corp Plc's Tysabri, were suspended in 2005 amid three reports of PML. The drug returned to the market in 2006 with limits, when the FDA decided patients were willing to accept the risk in light of the drug's benefits. The agency said it has also asked Novartis for related data and called on the drugmaker to update its prescribing information on Myfortic's label. The drugmaker does not provide specific sales figures for Myfortic because it is not one of its top 20 products. In a statement, Novartis said while it "is not aware of any instances of PML in patients using Myfortic, we will comply with the class label change requested by FDA."
Shares of Novartis were off 3.9 percent, or $1.90, at $47.27 in afternoon trading on the New York Stock Exchange; earlier they closed down 2.8 percent in Switzerland. Shares of Roche closed down nearly 1 percent on the Swiss exchange. (Reporting by Susan Heavey; editing by Gerald E. McCormick and Dave Zimmerman)
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