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PTA-News: NAVSTONE SE: Positive Geschäftsentwicklung im ersten Halbjahr 2021
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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: AstraZeneca-Alexion transaction cleared in the EU
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Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
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for the treatment of patients with chronic kidney disease
for millions of people in the EU suffering from chronic kidney disease AstraZeneca s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo.