Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if his Department will run trials of the drug Nusinersen.

Biogen Ltd submitted a marketing authorisation application for Nusinersen to the European Medicines Agency (EMA) in October 2016. The application has been approved for accelerated assessment by the Committee for Medicinal Products for Human Use who examine the evidence of the safety, efficacy and quality of new medicines proposed for licence in the European Union and is under assessment. Approval for accelerated assessment allows for faster assessment by EMA’s scientific committees (within up to 150 days rather than up to 210 days).

The Department’s National Institute for Health Research is currently in the pre-contracting stage of commissioning a Single Technology Appraisal on Nusinersen for treating infant or child spinal muscular dystrophy. The appraisal is due to begin in October 2017.