AstraZeneza has confirmed the safety of cardiovascular disease with Rosada results
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Last Update: 2021-02-16
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Source: Internet
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Author: User
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AstraZeneta has published the best results of its Global Phase III Rosadist Project Summary Cardiovascular (CV) Safety Analysis.One of the key CV safety endpoints is the main adverse CV event (defined as MACE), and the other key CV safety endpoint is assessed for MACE plus heart failure requiring hospitalization and unstable angina (defined as MACE).The state-of-the-art hypoxia-induced factor proline hydroxyase inhibitor (HIF-PHI) was evaluated in three separate tests:in a summary analysis of more than 4,300 MACE/MACE patients in nondialysis-dependent patients, the MACE/MACE analysis between Rosadis and placebo showed no clinical differences based on the overall judgment evidence.In a pool of 1,500 event (newly initiated) dialysis patients, MACE/MACE results showed that dialysis patients treated with Rosadat were better than those treated with epoetin alfa.In a summary analysis of approximately 4,000 dialysis-dependent patients, the MACE/MACE analysis between Rosadis and epoetin alfa showed no clinical differences."We are pleased to evaluate the data for these new drugs from the world's largest clinical program," said Mene Pangalos, Executive Vice President, Research and Development Biopharmaceuticals.After we announced in December 2018 that we were satisfied with the main therapeutic endpoints of the OLYMPUS and ROCKIES trials, these results add more and more positive evidence to support Rosadat's treatment of anaemia in patients with chronic kidney disease. Patients with chronic kidney disease have significant unsealed medical needs and we look forward to working with FibroGen to prepare for rosadis' regulatory submission. Thewill begin discussions with the U.S. Food and Drug Administration (FDA) for regulatory submission, which is expected later this year. (Compiled by this web)
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