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Novartis Reports Positive CHMP Opinion For Gene Therapy To Treat Retinal Disease

Novartis (NVS) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for the approval of voretigene neparvovec, a one-time gene therapy for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene. Luxturna was developed and is marketed in the US by Spark Therapeutics. If approved, voretigene neparvovec will be commercialized by Novartis in markets outside the U.S.

Separately, the company announced the CHMP has recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis. Gilenya was previously approved for adults with remitting forms of multiple sclerosis aged 18 years and older in Europe. The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months.

Also, Sandoz, a Novartis division, announced the CHMP has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim.

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