FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Biogen and Ionis Pharmaceuticals’ Spinraza Achieves Primary Endpoint

Nov. 14, 2016

Biogen and Ionis Pharmaceuticals’ investigational drug, Spinraza, for spinal muscular atrophy (SMA), met the primary endpoint at the interim analysis of the Phase 3 study evaluating the drug in later-onset (consistent with Type 2) SMA.

The analysis found that children receiving Spinraza experienced statistically significant improvement in motor function compared to those who did not receive treatment. Spinraza demonstrated a favorable safety profile in the study.

Biogen is preparing for the potential launch of Spinraza in the U.S. as early as the end of 2016 or the first quarter of 2017.

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