AZN - FDA Seeks Further Safeguards for AstraZeneca's Ultomiris Therapy But Efficacy Not in Question | Benzinga
The FDA has issued a complete response letter (CRL) regarding AstraZeneca Plc's (NASDAQ: AZN) supplemental Biologics License Application seeking approval for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+).
Neuromyelitis optica spectrum disorder (NMOSD), previously known as Devic disease or neuromyelitis optica, occurs when the body's immune system reacts against its ...