A woman in a Gilenya after-market study says the company didn’t notify all participants about the new case of PML.
Novartis executives have confirmed a multiple sclerosis (MS) patient has developed a rare brain infection after taking their drug Gilenya for more than four years.
The Switzerland-based pharmaceutical company posted a notice on their website announcing the development.
The website notice said the patient is doing well. It said the patient had been taking Gilenya for an extended period when he or she contracted progressive multifocal leukoencephalopathy (PML).
Novartis officials have released a statement that says the company has notified health authorities worldwide. They also informed more than 2,000 clinical trial investigators and physicians who treat MS. The company said it has followed up with additional physicians who treat MS patients. They provided information to patient advocacy organizations, too.
In late October, a patient in Europe died from PML after taking Tecfidera for more than four years. Biogen Idec Inc. manufactures that MS drug.
In 2013, the
In their web posting, Novartis officials noted Gilenya has a “positive benefit-risk profile” in relapsing-remitting MS patients based on experience with 114,000 people who have taken the drug.
One woman who is part of a current Gilenya after-market extension study said she learned about the most recent PML case after Novartis contacted another person in the study. The woman then found the announcement on the company’s website.
Her understanding is that the patient newly diagnosed with PML had never taken Tysabri, an older MS drug that has been linked to cases of PML in the past.
The woman in the extension study, who has MS, said she is well aware of the remote possibility of contracting PML while taking Gilenya, so she wasn’t surprised by the announcement. She was a bit miffed, however, that Novartis did not contact everyone in her study group or update their informed consent documentation.
“I’m not upset, but I am disappointed,” the woman said.
The Novartis statement said patients had not been contacted because the incident is still being investigated.
“As more data is pending, this case is still being reviewed by both Novartis and health authorities, including the FDA, and there is no new guidance to share regarding the use of Gilenya,” the Novartis statement reads. “Patients should talk with their doctors before making any changes in how they use Gilenya. We have therefore not communicated directly with patients. The safety and well-being of the people who take our medications is of the utmost importance. So, once we have agreed on a way forward with health authorities, we will work with them to promptly communicate more widely to Healthcare Professionals and the community, as appropriate.”
PML is a reactivation of the John Cunningham virus (JCV). JCV lives in the bodies of more than 75 percent of people in the United States. Most people’s immune systems are strong enough to keep the virus at bay.
People with weakened immune systems are at greater risk. That group includes people with AIDS, cancer patients taking chemotherapy drugs, transplant patients on anti-rejection drugs, and people taking immune-suppressing drugs for autoimmune conditions.