AstraZeneca’s Ultomiris Wins Accelerated US Approval
The FDA granted accelerated approval after a priority review, based on interim Phase III data showing a 43.4% reduction in proteinuria versus placebo at 34 weeks. The regulator said it has not yet been proven whether the drug...
Astrazeneca said the decision followed a priority review by the Food and Dug Administration and was based on interim Phase III data showing Ultomiris delivered a 43.4% reduction in proteinuria versus placebo at 34 weeks.However, the regulator stressed that it has not yet been proven whether the dru…