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Home » FDA Expands Approval of AstraZeneca Ultomiris Drug for Generalized Myasthenia Gravis Patients
FDA Expands Approval of AstraZeneca Ultomiris Drug for Generalized Myasthenia Gravis Patients
April 29, 2022
The FDA has approved AstraZeneca’s blockbuster drug Ultomiris (ravulizumab-cwvz) for the treatment of patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis — the third indication approval for the drug.
The expanded approval was based on positive results from a phase 3 study in which participants given the treatment showed a meaningful improvement at week 26 compared with those given a placebo.
The long-acting C5 complement inhibitor was previously approved for adult and pediatric patients at least one month old who have paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome.
AstraZeneca earned more than $1.8 billion from sales of Ultomiris in 2021.
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