Novartis AG Reports Third Case of PML in Relapsing MS Patient Treated with Gilenya

Published: Aug 19, 2015

Novartis AG Reports Third Case of PML in Relapsing MS Patient Treated with Gilenya
August 18, 2015
By Mark Terry, Breaking News Staff

Swiss-based Novartis announced yesterday that a third case of progressive multifocal leukoencephalopathy (PML) had been reported in a patient being treated with Gilenya. The patient was being treated for relapsing multiple sclerosis (RMS) and had a history of colorectal cancer, as well as the inflammatory bowel disease, Crohn’s.

The company indicates the case has been reported to health regulators and is reviewing details. It also points out than more than 125,000 patients have been treated with Gilenya.

PML is a rare and often fatal viral infection. Symptoms involve progressive inflammation of the white matter in the brain at various locations. It is caused by the John Cunningham virus (JCV), which is usually controlled by the body’s immune system. It is typically seen in patients who are immunocompromised, such as AIDS patients, cancer patients on chemotherapy, transplant patients taking anti-rejection drugs, and patients receiving immuno-suppressing drugs for autoimmune disorders.

In March 2015, Novartis confirmed an MS patient had developed PML after taking Gilenya for more than four years. In 2013, the U.S. Food and Drug Administration (FDA) announced that a patient in Europe taking Gilenya had been diagnosed with PML.

The FDA reported, “The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.”

In 2014, a patient being treated for RMS, using Biogen Idec, Inc. ’s Tecfidera (dimethyl fumarate) died from PML. That patient was participating in the ENDORSE clinical trial. “This patient was treated with Tecfidera for 4.5 years as part of the ENDORSE study,” said Catherine Falcetti, associate director of public affairs for Biogen, Inc. in an interview with Healthline at the time. “They developed PML and recently died due to complications associated with aspiration pneumonia.”

Most MS drugs have an impact on the immune system, typically suppressing T and B-cells to slow the disease, which is characterized with inflammation. Although it helps control MS, it can make patients more susceptible to viral and bacterial infections.

“The occurrence of PML is not limited to people who have MS, and even if a person has been exposed to the virus and has taken immune-modulating therapies, it does not mean that they will develop PML,” said Bruce Bebo, Jr., executive vice president of research for the National Multiple Sclerosis Society in a 2014 Healthline interview. “So far, in people with MS, PML has occurred mostly in people who have taken natalizumab (Tysabri).”

The most recent statement from Novartis says it “continues to stand behind the positive benefit-risk profile of Gilenya in relapsing MS.” It had also recently updated the prescribing information for Gilenya to increase awareness for PML.

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