Biopharmaceutical Company Submits SMA-Targeted Apitegromab for FDA Biologics License
Scholar Rock, a Cambridge, Massachusetts-based late-stage biopharmaceutical company, has submitted a Biologics License Application to the U.S. Food & Drug Administration (FDA) for apitegromab, described as “a muscle-targeted therapy designed and developed to provide clinically meaningful improvement in motor function for people living with SMA [spinal muscular atrophy] who are receiving SMN [survival motor neuron]-targeted treatments.”
In a Jan. 29 news announcement, Scholar Rock said it’s asked for a priority review. If granted, the priority review would “shorten the FDA’s review time to six months from the date of filing acceptance,” the company said.
Cure SMA, an advocacy organization for children and adults living with spinal muscular atrophy, said in a Jan. 29 comment on the announcement, “To note, the FDA has granted apitegromab Fast Track, Orphan Drug and Rare Pediatric Disease Designations in SMA.”
Research: Somatosensory Stimulation on Wrist Can Affect Hand-Choice Decisions
New research published in Scientific Reports showed that somatosensory electrical stimulation applied to a subject’s wrist can cause the subject to favor the stimulated hand.
In a December announcement of the study — Somatosensory stimulation on the wrist enhances the subsequent hand-choice by biasing toward the stimulated hand — researchers said, “This discovery highlights a potential breakthrough in stroke rehabilitation by encouraging use of the affected hand. The findings also deepen our understanding of how sensory input influences motor decision making.”
Researchers noted that hand choice is “an unconscious decision … influenced by target-related information, but if these are non-informative, the choice will be approximately 50-50. Non-target information may also aid in decision making, but no research has demonstrated this.”
The research team was led by Dr. Kento Hirayama (Waseda University and the University of Southern California), Dr. Rieko Osu (Waseda University), and Dr. Toru Takahashi (Waseda University and the Laureate Institute for Brain Research).
