A patient who was taking Novartis AG’s multiple sclerosis pill, Gilenya, contracted a severely harmful (and often deadly) viral brain infection known as multifoclal leukoencephalopathy (or PML for short). The patient was also taking a Biogen Idec Inc. medicine known as Tysabri, an injection known to increase the risk of PML. Since 2006, Tysabri’s warning label has informed patients that taking the medication can increase the risk of PML.
Novartis said that the Tysabri was most likely the cause of the infection, but did not rule out the possibility that Gilenya was a contributing factor. Regardless, the infection has Novartis worried because regulators are currently looking into the unexplained deaths of 11 Gilenya patients since the drug was approved in 2010. Over 36,000 people have taken the drug since its approval, but regulators are investigating the 11 deaths as part of a broader look into Gilenya’s safety and efficacy.
Gilenya is predicted to become a blockbuster drug for Novartis, with analysts saying that the drug will be garnering about $2.06 billion in annual sales by 2015.
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