Biogen announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorization for SPINRAZA (nusinersen) to treat patients with spinal muscular atrophy (SMA). The CHMP reviewed SPINRAZA under an accelerated assessment program, which is a regulatory mechanism to facilitate earlier access to patients for medicines that fulfill unmet medical needs. SPINRAZA is the first treatment for SMA to be recommended by the CHMP for approval in the European Union (EU).
“The positive CHMP opinion, which was expedited under the accelerated assessment program, recognizes the compelling efficacy profile of SPINRAZA and underscores the significant unmet need for an effective SMA treatment in Europe,” said Michael Ehlers, M.D., Ph.D., executive vice president, Research and Development at Biogen. “We look forward to the European Commission’s decision and believe SPINRAZA has the potential to make a meaningful impact for individuals with SMA in the EU.”
The CHMP positive opinion is now referred to the European Commission (EC), which grants the marketing authorization for centrally authorized medicines in the EU. The CHMP recommended an indication for the treatment of 5q SMA, which refers to the most common form of the disease and represents approximately 95% of all SMA cases. A decision from the EC is expected in the next few months.