Roche Gets EU Recommendation for Evrysdi for Babies Under Two Months
July 21 2023 - 10:25AM
Dow Jones News
By Sarah Sloat
Swiss pharma company Roche said Friday it has received a
positive opinion from the European Union that would extend use of
its Evrysdi treatment for babies diagnosed with spinal muscular
atrophy.
The positive recommendation from the EU Committee for Medicinal
Products for Human Use, or CHMP, is based on interim data from an
ongoing trial that showed most babies treated with Evrysdi were
able to stand and walk within timeframes typical of healthy babies
by 12 months of treatment, Roche said.
Evrysdi is currently approved in the EU for treating patients
two months or older.
Specifically the recommendation to extend marketing
authorization includes treatment for infants with genetically
confirmed diagnosis of different types of spinal muscular atrophy
from birth to below two months.
Write to Sarah Sloat at sarah.sloat@wsj.com
(END) Dow Jones Newswires
July 21, 2023 10:10 ET (14:10 GMT)
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