Oral MS drug Gilenya reviewed by EU after 11 patient deaths

Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.

Oral MS drug Gilenya reviewed by EU after 11 patient deaths

Postby MSUK » Fri Jan 20, 2012 7:05 am


The European Medicines Agency started a review of Novartis AG’s Gilenya pill for multiple sclerosis after 11 deaths among patients who received treatment.

The reports raise concern that the drug, the first oral medicine for the debilitating neurological disease, may harm the heart, the London-based agency said in an e-mailed statement today. Eric Althoff, a spokesman for Novartis in Basel, Switzerland, didn’t immediately return a call and e-mail requesting comment.

Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya. Ten other deaths have been reported among patients who began taking Gilenya, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the agency said today. It isn’t clear what role if any Gilenya had in the deaths, EMA said....Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309
MS-UK - http://www.ms-uk.org/
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