Fast-track designation will allow Biohaven to get the treatment to patients faster, facilitating more frequent FDA communication and expeditious drug review.
Taldefgrobep has the possibility to be used in conjunction with disease-modifying therapies to enhance muscle function by blocking myostatin activity.
Biohaven is currently enrolling patients for a phase 3 clinical trial of taldefgrobep.
“Fast track designation from the FDA underscores the high unmet medical need in SMA and supports the need for additional novel combination therapies in children and adults living with this progressive neurologic disease,” Karen Chen, PhD, CEO of the Spinal Muscular Atrophy Foundation, said in a Feb. 21 press release.
