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.
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
