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November 15, 2015

Zambon’s Xadago gets Swissmedic approval to treat Parkinson’s disease

The Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for Xadago (safinamide) to treat Parkinson’s disease.

The Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for Xadago (safinamide) to treat Parkinson’s disease.

Being developed by Zambon and its partner Newron Pharmaceuticals, Xadago has been approved as add-on therapy to levodopa (L-dopa) alone or in combination with other Parkinson’s therapies for patients in mid-to late-stage and motor fluctuations.

Xadago contains active substance safinamide, a monoamine oxidase-B (MAO-B) inhibitor and it blocks the enzyme monoamine oxidase type B, which breaks down dopamine and helps to restore dopamine levels in the brain, enhancing the patient’s symptoms.

"We keep on working to ensure this new chemical entity will be available to all the patients in need of innovative therapies in Parkinson’s disease."

During long-term double-blind controlled studies, Xadago demonstrated significant effects on motor fluctuations without increasing the risk of developing dyskinesia.

Zambon CEO Maurizio Castorina said: "This approval by Swissmedic is a further evidence of the acceptance of the benefits offered by Xadago (safinamide) by another regulatory authority.

"We keep on working to ensure this new chemical entity will be available to all the patients in need of innovative therapies in Parkinson’s disease."

Zambon holds the rights to develop and commercialise safinamide globally, excluding Japan and several other Asian territories.

Parkinson’s disease affects around 1% of the population over the age of 55 years, with a male-to-female ratio of 3:2.

It is the second most common chronic progressive neurodegenerative disorder and can be diagnosed based on observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia.

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