Biohaven’s taldefgrobep alfa receives FDA Fast Track designation for SMA

Biohaven received Fast Track designation from the FDA for taldefgrobep alfa, a novel anti-myostatin adnectin, for the treatment of spinal muscular atrophy, or SMA. Fast Track designation enables important new drugs to reach patients earlier by facilitating more frequent communications with the FDA and expeditious review of a drug which treats a serious condition and fills an unmet medical need. Biohaven previously received orphan drug designation from the FDA for taldefgrobep in the treatment of SMA. Taldefgrobep has the potential to be a novel therapy to be used in combination with disease modifying therapies to enhance muscle function by blocking myostatin activity. Taldefgrobep’s novelty in a field of myostatin inhibitors is based on its mechanism of action. Biohaven is currently enrolling a Phase 3 clinical trial of taldefgrobep in SMA.