Alexion Pharma (ALXN) Announces Upcoming Data Presentations at the 26th European Hematology Association Virtual Congress
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Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that five abstracts have been accepted for presentation at the 26th annual European Hematology Association (EHA) 2021 virtual Congress, taking place from June 9 through June 17, 2021. During the meeting, data will be presented further supporting the long-term safety of ULTOMIRIS® (ravulizumab-cwvz) over two years, including reduction of thrombotic (blood clot) risk, in complement inhibitor-naïve and complement inhibitor-experienced patients with PNH, and reaffirming the critical role of complete C5 complement inhibition in treating this rare disease.
Also being presented are new Phase 3 interim analysis data that evaluate the efficacy and safety of ULTOMIRIS in pediatric patients as well as the previously announced topline Phase 3 results for the weekly subcutaneous formulation of ULTOMIRIS in adults with PNH.
“Our data presentations at this year’s EHA Congress underscore the clinical value of ULTOMIRIS – the standard of care for adults living with PNH – and continue to build on its well-established safety and efficacy profile,” said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion. “These data also demonstrate further progress in our efforts to continue innovating for patients – supporting the use of ULTOMIRIS in children and adolescents and via a convenient, self-administered subcutaneous formulation.”
The U.S. Food and Drug Administration (FDA) granted priority review for ULTOMIRIS in children and adolescents with PNH and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 7, 2021. The interim analysis that will be presented at EHA is from the largest study of pediatric PNH patients to date.
The accepted abstracts are listed below and are now available on the EHA website. All e-poster presentations will be made available on the virtual congress platform on June 11, 2021 at 09:00 CEST (3:00 a.m. EDT) and will be available throughout the duration of the Congress.
Ravulizumab Reduces the Risk of Thrombosis in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria and High Disease Activity: 2-Year Data from A Phase 3, Open-Label Study. Oral presentation ID #S301. The pre-recorded oral presentation will be published on the virtual Congress platform on June 11, 2021 at 09:00 CEST (3:00 a.m. EDT), with a live Q&A session on June 14, 2021. The session begins at 11:00 CEST (5:00 a.m. EDT).
Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Ravulizumab In Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria: Interim Analysis of A Phase 3, Open-Label Study. ePoster presentation, abstract ID #EP590.
Safety of Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria: Study 301/302 2-Year Results. ePoster presentation, abstract ID #EP594.
Ravulizumab and Eculizumab Reduce Transfusions in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria: Evidence from Three Real-World Databases: TriNetX US EMR, TriNetX US Claims and KOMODO Health. ePoster presentation, abstract ID #EP1337.
Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients with PNH Previously Treated with Eculizumab: Results from A Phase 3 Randomized, Open-Label Study. ePoster presentation, abstract ID #EP586.
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Create E-mail Alert Related CategoriesCorporate News, FDA
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