Roche: CHMP greenlights SMA
(CercleFinance.com) - Swiss pharma group Roche has received a positive opinion from the CHMP for Evrysdi, the first and only home treatment for spinal muscular atrophy (SMA) which has been shown to be effective in adults, children and infants of two months old and above
SMA causes progressive muscle weakness and atrophy.
Significant unmet needs remain, especially in adults with this disease.
The CHMP recommendation has been completed as part of the accelerated assessment procedure, which is offered to medicinal products considered to be of major interest for public health and therapeutic innovation.
A final decision on the approval is expected from the European Commission in the next two months and will be applicable to the 27 member states of the European Union, as well as Iceland, Norway and Liechtenstein.
Evrysdi was approved by the United States Food and Drug Administration (FDA) in August 2020.
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