Novartis wins EU nod for presumed MS blockbuster Gilenya

Novartis' ($NVS) new multiple sclerosis pill now has both sides of the Atlantic covered. The company won European regulators' blessing to market Gilenya, the first oral MS treatment, after last year's nod from FDA. The European Medicines Agency approved Gilenya as a second-line treatment for people with highly active relapsing-remitting MS, or as a first treatment for patients with "rapidly evolving" disease.

"Today's announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients," Novartis' David Epstein said in a statement. 

Given the recent stumbles by its potential rival, Merck KGaA's cladribine, Gilenya has a wide-open market all to itself--probably for some time. Indeed, in approving Gilenya, the EMA actually questioned the utility of Merck's drug and another experimental oral treatment in development at Biogen Idec.

The European approval isn't as broad as the FDA's, Bloomberg points out. But with first-to-market advantage, Gilenya is still seen as a sure blockbuster. Analysts say it has the potential to grow to more than $3 billion in annual sales. That could go a long way toward filling the sales gaps created as big Novartis drugs--including Diovan--go off patent.

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