Spinraza Recommended for Approval in Europe

The new spinal muscular atrophy (SMA) treatment Spinraza has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medical Association (EMA).

MORE: Nine commonly asked questions about Spinraza. 

Biogen, the makers of the drug, made the announcement in a press release. The news means that children and adults with all types of SMA in Europe may soon be able to start treatment on Spinraza (also known as nusinersen). If approved by the EMA, it will be the first treatment available for people with the disease in Europe, following the U.S. approval of the drug in December.

The positive opinion of Spinraza has now been referred to the European Commission (EC) and a decision regarding the approval should happen over the coming months. Find out more about the positive opinion of Spinraza in Europe here. 

MORE: Child with SMA labeled a “lazy baby” by doctors is now thriving on Spinraza.

SMA News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Leave a Comment

Your email address will not be published. Required fields are marked *