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EU approval of Mayzent® (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease

Posted in Industry News on 21st Jan 2020

On 20th January 2020, Novartis announced that Mayzent® (siponimod) has been approved as the first and only oral treatment specifically indicated for patients with secondary progressive multiple sclerosis (SPMS) with active disease in Europe.1

Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population.

Approval is based on the Phase III EXPAND trial, the largest randomised clinical study in a broad range of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including physical disability and cognitive decline2,3

Read more here.

References

  1. National MS Society Brochure. Disease Modifying Therapies for MS. http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf. Accessed January 2020.
  2. Kappos L, Cree B, Fox R, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomized, phase 3 study. Lancet. Published online March 22, 2018. http://dx.doi.org/10.1016/S0140-6736(18)30475-6.
  3. Mayzent® (siponimod) Summary of Product Characteristics. Novartis International AG. January 2020.