Updated on 1 August 2013
Novartis in big trouble – The company admits that a patient taking its multiple sclerosis (MS) drug Gilenya for the past seven months developed progressive multifocal leukoencephalopathy (PML)
Singapore: Novartis pointed out that a patient taking its multiple sclerosis (MS) drug Gilenya for the past seven months developed a rare and potentially fatal viral disease called progressive multifocal leukoencephalopathy (PML). Gilenya is one of Novartis' latest blockbuster drugs, growing 66 percent in the second quarter to $468 million.
Novartis is working with the reporting physician to understand all possible contributing factors, including those beyond treatment, given several atypical features of the case.
Novartis revealed that all previously reported cases of PML among the 71,000 patients treated with Gilenya so far had been attributed to prior treatment with Biogen Idec's Tysabri, which is the major competitor of the Novartis drug.
Novartis said in a statement that, "The course of the underlying neurological disease was rapid with some atypical findings for MS on the MRI scans of the brain and spinal cord, as well as some unusual clinical features."