European Medicines Agency

EUROPEAN MEDICINES AGENCY NEWSROOM (4 press releases)

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GlaxoSmithKline: US FDA regulatory submission acceptance of New Drug Application for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor

PRESS RELEASE -- 19, April 2022

(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 →

GlaxoSmithKline: European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor used to treat patients with anaemia of chronic kidney disease

PRESS RELEASE -- 1, March 2022

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 →

AstraZeneca receives EU approval for its Saphnelo, the only new medicine in over a decade for patients with systemic lupus erythematosus

PRESS RELEASE -- 16, February 2022

(PRESS RELEASE) CAMBRIDGE, 16-Feb-2022 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced an European Union (EU) approval for its Saphnelo (anifrolumab) medicine as an add-on therapy for the treatment of adult patients with … Read the full press release →

Roche to present new two-year data for its Vabysmo and Susvimo at Angiogenesis, Exudation and Degeneration 2022 on 12 February

PRESS RELEASE -- 11, February 2022

In the YOSEMITE and RHINE studies in diabetic macular edema, at least 60% of eligible Vabysmo patients could extend treatment to every four months at two years, compared to 50% at year one Almost 80% of eligible Vabysmo patients could extend treatment to every … Read the full press release →