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Roche pharmaceuticals receives positive CHMP opinion for Evrysdi, the first at home treatment for SMA
March 4th, 2021
Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven effectiveness in adults, children and infants two months and older.
Roche pharmaceuticals has recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
- In two pivotal clinical studies, Evrysdi showed event-free survival and motor milestone improvements never previously achieved in the natural history of the condition
- More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings
- Evrysdi is approved in seven countries, submitted in 30 more.
For more details, follow this link https://www.roche.com/dam/jcr:ef68bb9a-9149-40e4-ac66-fd1c891adeec/en/26022021-mr-chmp.pdf