Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)

A Multicenter, Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium) When Used in Routine Medical Practice in Korea

The primary objective is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in Korea. The secondary objective is to evaluate the effectiveness of nusinersen sodium injection in the postmarketing setting in Korea.

Key Inclusion Criteria:

• Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting
• Genetic documentation of 5q-linked SMA

Key Exclusion Criteria:

• Hypersensitivity to the active substance or any of the excipients of Spinraza
• Ongoing participation or participation within 6 months or 5 half-lives of the agent (whichever is longer) of enrollment in other interventional clinical trials for the treatment of SMA
• Inability to comply with study requirements

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.