Biogen’s salanersen gains FDA breakthrough therapy designation for SMA

Biogen has received the breakthrough therapy designation from the FDA for salanersen (BIIB115), an investigational treatment for SMA. The FDA's decision follows data from a Phase Ib study on salanersen. SMA is a rare, genetic neuromuscular disease leading to progressive muscle weakness due to the loss of motor neurons. Credit: Panchenko Vladimir / Shutterstock.com. Biogen has received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for salanersen (BIIB115), an investigational treatment for spinal muscular atrophy (SMA). This advance recognises preliminary data indicating that salanersen may show substantial improvement over existing therapies for SMA. LOA and PTSR…

Source: Pharmaceutical Technology