Biogen to Initiate P-II/III DEVOTE Study Evaluating the Higher Doses of Spinraza (nusinersen) for Spinal Muscular Atrophy

Shots:

• The P-II/III DEVOTE study will evaluate the higher doses of Spinraza in 126 patients with SMA of all ages. The three-part study will include an open-label safety study followed by an open-label treatment period
• The study will compare two loading doses of Spinraza (50mg) 15days apart followed by a maintenance dose of 28 mg every 4mos. with FDA approved dose of Spinraza (4 loading doses with 12mg maintenance dose every 4mos.). The third part of the study will determine the safe & efficient transition of patients from the currently approved dose to the higher dose being evaluated in the study
• Spinraza is the first therapy to be approved for SMA in infants, children & adults, demonstrated an improvement in or stabilization of motor function in patients aged ≤21yrs. in a SHINE study for nearly 6yrs.

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