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Home Industry News Novartis receives EU approval for MS drug Gilenya

Novartis receives EU approval for MS drug Gilenya

22nd March 2011

Novartis has been granted approval from European regulators for the launch of its innovative new multiple sclerosis (MS) drug Gilenya.

The European Commission has ratified the product as a therapy for highly active relapsing-remitting MS sufferers who have proven unresponsive to treatment with beta interferon.

This approval was based on positive data from a large-scale clinical trial programme and means that Gilenya has now become the first oral MS drug approved for sale in the EU.

It was originally licensed from Mitsubishi Tanabe Pharma Corporation and has been in clinical development since 2003, with more than 4,000 MS patients involved in the process.

David Epstein, division head of Novartis Pharmaceuticals, said: "Today's announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients."

Earlier this month, the company was granted a recommendation from Europe's Committee for Medicinal Products for Human Use for its drug Lucentis to be approved as a macular edema treatment.ADNFCR-8000103-ID-800471132-ADNFCR

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