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Alexion Announces Positive Topline Results from Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Adults with Generalized Myasthenia Gravis (gMG)

Alexion Announces Positive Topline Results from Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Adults with Generalized Myasthenia Gravis (gMG)
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Alexion Provides Update on Phase 3 Study of ULTOMIRIS (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19

adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
It is not known if ULTOMIRIS is safe and effective in children with PNH.
It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. ....

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Alexion Provides Update on Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19

Press release content from Business Wire. The AP news staff was not involved in its creation.
Alexion Provides Update on Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19
January 13, 2021 GMT
BOSTON (BUSINESS WIRE) Jan 13, 2021
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS ® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis. The IDMC recommended that additional enrollment be paused, pending further analysis of the data, due to lack of efficacy when ULTOMIRIS was added to best supportive care, compared to best supportive care alone. There were no new safety findings observed. The study will continue for patients already enrolled, ....

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