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Fingolimod News

Use of MS Drug, Gilenya (Fingolimod), Expanded to Include Children

Posted 14 May 2018 by

MONDAY, May 14, 2018 – The U.S. Food and Drug Administration has expanded its approval of the multiple sclerosis drug Gilenya (fingolimod) to include children aged 10 and older. It's the first multiple sclerosis drug approved for children, the agency said in a news release. The drug was approved in 2010 to treat adults with relapsing MS. Multiple sclerosis is a chronic central nervous system ...

FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients

Posted 13 May 2018 by

May 11, 2018 – The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients. “For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Billy Dun ...

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the ...

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection

Posted 4 Aug 2015 by

ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, ...

FDA Medwatch Alert: Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection

Posted 29 Aug 2013 by

ISSUE: FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of progressive multifocal leukoencephalopathy (PML), reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS ...

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

Posted 15 May 2012 by

[UPDATED 05/14/2012] FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. FDA could not definitively conclude that Gilenya was related to any o ...

FDA Issues Multiple Sclerosis Drug Alert

Posted 14 May 2012 by

MONDAY, May 14 – The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, says a U.S. Food and Drug Administration safety announcement issued Monday. The warning follows the FDA's evaluation of a report of a patient who died within 24 hours ...

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

Posted 20 Dec 2011 by

[Posted 12/20/2011] ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation. BACKGROUND: Gilenya ...

Experimental MS Drug Shows Promise

Posted 5 Oct 2011 by

WEDNESDAY, Oct. 5 – A new oral drug for relapsing forms of multiple sclerosis appears to reduce relapse rates and disability progression, according to the results of a so-called phase 3 trial. The experimental drug, teriflunomide, is one of the few oral drugs that treat this type of MS and may, if approved, be a good choice for many MS patients, researchers said. "Basically, these are very good ...

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