FDA to update Novartis' Gilenya label with brain-infection risk warning
- The FDA is adding information to the labeling for Novartis' Gilenya (fingolomid), used to treat relapsing multiple sclerosis (RMS), detailing risks of treatment-related brain infections.
- Two cases of brain infection associated with Gilenya treatment for RMS have been reported—a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML.
- PML tends to be a concern for RMS patients who have been in long-term treatment with various drugs, including Biogen's Tecfidera and Tysrabi. But this is the first time that patients who have not previously been treated with an immunosuppresant have experience PML
Gilenya has been a positive addition to the armamentarium of drugs used to treat RMS, because it is a once-a-day oral drug that basically cuts the number of relapses experienced by a patient in half, according to clinical data.
And given the fact that more than 2.3 million people are affected by different types of MS, there continues to be a need for a variety of effective treatment options. Nonetheless, PML is a challenge that is associated with treatment of MS patients who have taken immunosuppressants. It is caused by a common virus which normally does not wreak havoc in a person who is not immunocompromised. Symptoms include vision problems, confusion, changes in personality, and possibly permanent disability or even death.
The investigation of Gilenya-related PML dates back to 2013, when the FDA started investigating a potential link. Now that it has been figured out and the label has been updated, patients and physicians have fair warning and can move forward with their decision-making regarding using Gilenya as part of their regimen.