It has been approved for treating 5q 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, it said.
ZURICH: Roche's Evrysdi has won approval from the European Commission as the first and only at-home treatment for spinal muscular atrophy (SMA), the Swiss drugmaker said on Tuesday.
It has been approved for treating 5q 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, it said.
The drugmaker said it was working with reimbursement and assessment bodies in European countries to enable broad and rapid access. Rival treatments include Zolgensma from Novartis and Biogen's Spinraza.
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