UCB: Rozanolixizumab BLA for myasthenia gravis filed with FDA, tagged for Priority Review

 

• Biologic License Application (BLA) designated Priority Review by FDA and seeks approval for rozanolixizumab for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetycholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
• Rozanolixizumab FDA Priority Review follows recent European Medicines Agency (EMA) validation of the Marketing Authorization Application (MAA) for rozanolixizumab in adults with gMG
• FDA and EMA submissions based on pivotal Phase 3 MycarinG study in gMG which demonstrated treatment with rozanolixizumab resulted in clinically meaningful and statistically significant improvements in MG specific outcomes
• UCB expects to receive feedback from the agencies in Q2 of 2023

https://www.biospace.com/article/releases/ucb-announces-rozanolixizumab-bla-for-the-treatment-of-generalized-myasthenia-gravis-filed-with-u-s-fda-and-designated-for-priority-review/