EU supports oral MS drug, Gilenya, with stronger warning

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

EU supports oral MS drug, Gilenya, with stronger warning

Postby MSUK » Fri Apr 20, 2012 5:43 am


European regulators have endorsed the continued use of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, but said on Friday the drug needed to carry stronger warnings on heart risks.

Novartis said the decision meant the drug remained on-track to be a "blockbuster" - one with annual sales above $1 billion.

Prospects for Gilenya, the first multiple sclerosis (MS) pill of its kind, have been clouded by reports of its association with serious heart problems.

The European Medicines Agency (EMA), which had initially aimed to give an update on Gilenya last month, said doctors should not prescribe it to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering medication.... Read More - ... ageid/1309
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