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Evrysdi treats spinal muscular atrophy (SMA), CHMP holds positive opinions

 Last Update: 2021-03-21
 Source: Internet
 Author: User

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Roche today announced that the European Medicines Management Agency (EMA) Committee for Medicinal human use (CHMP) has recommended approval Evrysdi ™ (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) 2 months and older patients who suffer Type 1, Type 2, or Type 3 or one to four SMN2 copies of SMA.

management

SMA is the main genetic cause of infant death, and 5q SMA is the most common form of the disease.

CHMP recommendations are based on data from FIREFISH clinical studies.

In FIREFISH, according to the Bayley scale's total exercise scale assessment, 29% (12/41) of infants treated with Evrysdi for 12 months were able to sit for at least five seconds without support.

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