March 21, 2011 / 7:00 AM / 7 years ago

UPDATE 1-Novartis receives EU approval for Gilenya

* Gilenya is first oral multiple sclerosis treatment in EU

* European green light follows U.S. approval in September

* Gilenya seen as potential blockbuster

(Adds further details, background)

ZURICH, March 21 (Reuters) - Swiss drugmaker Novartis AG NOVN.VX said the European Commission approved its multiple sclerosis pill Gilenya, a potential blockbuster that should help it cope with price pressures and competition from generics.

Gilenya is approved in the European Union for people with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS, Novartis said on Monday.

“Today’s announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients,” said David Epstein, division head of Novartis pharmaceuticals, quoted in the statement.

The pharmaceutical industry is grappling with price pressures in the wake of European austerity measures and the U.S. healthcare reform and competition from generics and Novartis relies on promising new drugs like Gilenya to boost its sales.

Gilenya’s first-mover advantage may allow it to dominate the market and some analysts believe it could become a $3 billion-a-year-plus seller.

The European Medicines Agency had recommended approval of the treatment in January, following the green light in the United States in September, where the treatement has gone on sale at an average annual cost of $48,000 per patient. [ID:nLDE69L08A]

Gilenya was designed to treat patients with relapsing multiple sclerosis (MS), the commonest form of the debilitating disease, and its convenient dosing and efficacy is expected to make it a popular alternative to current injections.

More than 500,000 people in the European Union live with MS, a neurological condition that leads to a range of complex and unpredictable symptoms. (Reporting by Silke Koltrowitz; Editing by Mike Nesbit)

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