Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment of adults with myasthenia gravis who are anti-acetycholine receptor or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
UCB today announced that the US FDA has accepted the company’s filing to review a biologic license application for its investigational treatment rozanolixizumab, and that the Agency has granted priority review.
