Ultomiris
FDA Expands AstraZeneca's Indication for C5 Protein Inhibitor Ultomiris
Ultomiris is approved for adult patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder, a rare autoimmune disease.
AstraZeneca Gets FDA Complete Response Letter to Application Seeking Ultomiris Approval in NMOSD
The firm said the agency wants enhancements to the risk mitigation strategy for the drug in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.