Posted by Michael Wonder on 22 Apr 2017
Biogen’s Spinraza (nusinersen) receives positive CHMP opinion for the treatment of spinal muscular atrophy
21 April 2017 - First SMA treatment recommended for approval in the EU.
Biogen today announced the CHMP of the EMA adopted a positive opinion recommending the granting of a marketing authorisation for Spinraza (nusinersen) to treat patients with spinal muscular atrophy.
The CHMP reviewed Spinraza under an accelerated assessment program, which is a regulatory mechanism to facilitate earlier access to patients for medicines that fulfil unmet medical needs.
Spinraza is the first treatment for SMA to be recommended by the CHMP for approval in the European Union.
