Gene Therapy Zolgensma Receives Approval from the European Commission.
AveXis announced that the European Commission has given conditional approval for Zolgensma on May 19, 2020. This confirmation is valid for SMA patients who have clinically been diagnosed with SMA type 1 or who have highest 3 SMN2 gene copies. In addition it covers infants and young children with SMA of 21 kg or less.
For SMA patients and their relatives, Zolgensma's EC approval is a very important development. AveXis president, Dave Lennon said in a statement; "even under current pandemic conditions, the treatment of SMA disease is in urgent need, and they are in contact with more than 100 stakeholder organizations across Europe to discuss the "One Day" outreach program."