European agency backs approval of Novartis' oral MS drug Gilenya

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Novartis' oral drug Gilenya (fingolimod) as a treatment for patients with multiple sclerosis, the company announced. Vontobel analyst Andrew Weiss indicated that if approved, Germany, Britain, France, the Netherlands, and Italy would likely be the first European markets where the product will be launched.

Specifically, Novartis noted that the CHMP recommended approval of Gilenya as a disease modifying therapy in patients with highly active relapsing-remitting MS despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS. The company said the decision was based on clinical data showing "significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions" in patients with MS treated with the drug.

Gilenya became the first oral compound to be approved in the US as a first-line treatment for relapsing forms of MS when it was cleared by the FDA last September. Several other companies are developing oral MS therapies, although analysts believe that being first to market will allow Novartis' drug to generate annual revenue of $3 billion or more, with UBS analyst Fabian Wenner predicting the product could even achieve sales of $5.3 billion per year by 2016.

Merck KGaA's oral drug cladribine is under review in both Europe and the US, although regulators in the former market confirmed a negative decision recommending against approval. The FDA is scheduled to finish its review by February, after extending it last year.

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