(PRESS RELEASE) LONDON, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON: GSK), a British multinational science-led healthcare company, has announced the third major regulatory milestone for its daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of … Read the full press release
(COMMUNIQUÉ DE PRESSE) LONDRES, 19-Apr-2022 — /EuropaWire/ — GlaxoSmithKline plc (LON : GSK), une multinationale scientifique britannique , a annoncé la troisième étape réglementaire majeure pour son daprodustat, un inhibiteur oral du facteur prolyl hydroxylase inductible par l’hypoxie (HIF-PHI), pour le … Read the full press release
Zulassungsantrag für die Behandlung von Anämie bei chronischer Nierenerkrankung basierend auf dem klinischen Phase-III-Studienprogramm ASCEND, bestehend aus fünf Studien, die alle ihre co-primären Wirksamkeits- und Sicherheitsendpunkte erreichten Die Zulassung der EMA-Anträge ist der erste große regulatorische Meilenstein für Daprodustat seit … Read the full press release
Posted in Healthcare, Marketing, Pharma & Biotech, United Kingdom
Tagged American Society of Nephrology, Anämie, ASCEND-D, ASCEND-ND, Behandlung von Anämie, chronische Nierenerkrankung, CKD, daprodustat, Dialyse, EMA, Europäische Arzneimittel-Agentur, GlaxoSmithKline, Hämoglobin, HIF-PHI, klinisches Studienprogramm ASCEND Phase III, MAA, Prolylhydroxylase-Hemmer, Zulassungsantrag
Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints EMA file acceptance is the first major regulatory … Read the full press release
Posted in Healthcare, Marketing, News, Pharma & Biotech, United Kingdom
Tagged American Society of Nephrology, anaemia, ASCEND Phase III clinical trial programme, ASCEND-D, ASCEND-ND, Chronic kidney disease, CKD, daprodustat, dialysis, EMA, European Medicines Agency, GlaxoSmithKline, haemoglobin, HIF-PHI, MAA, Marketing Authorisation Application, prolyl hydroxylase inhibitor, treatment of anaemia
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