Posted by Michael Wonder on 29 Apr 2021
Biogen provides regulatory update on the supplemental biologic license application for subcutaneous administration of Tysabri (natalizumab)
28 April 2021 - Biogen today announced that it has received a complete response letter from the U.S. FDA for its supplemental biologic license application for a new subcutaneous route of administration of Tysabri (natalizumab) to treat relapsing multiple sclerosis.
The letter indicates that the FDA is unable to approve the Company’s filing as submitted.
Biogen is evaluating the complete response letter and will determine next steps in the U.S.
