US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer
Pressmeddelanden • Apr 19, 2018 08:01 CEST
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.
Updated overall survival data for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer presented at AACR
Pressmeddelanden • Apr 16, 2018 08:01 CEST
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data from the Phase III OlympiAD trial showing the final overall survival (OS) results for Lynparza (olaparib) in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, US, 14-18 April 2018.
1st-line Tagrisso demonstrates sustained benefit post progression in patients with EGFR-mutated non-small cell lung cancer
Pressmeddelanden • Apr 13, 2018 16:58 CEST
AstraZeneca today presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC
Pressmeddelanden • Apr 04, 2018 12:01 CEST
AstraZeneca and MedImmune, its global biologics research and development arm, will present updates from their early and late stage oncology pipelines at two major congresses this month. In total, 98 abstracts were accepted for the European Lung Cancer Conference (ELCC) in Geneva,11-14 April, and the American Association for Cancer Research (AACR) annual meeting in Chicago,14-18 April.
The European Medicines Agency accepts regulatory submission for Lynparza in BRCA-mutated, HER2-negative metastatic breast cancer
Pressmeddelanden • Apr 03, 2018 08:03 CEST
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib).
US FDA accepts Biologics License Application for moxetumomab pasudotox in hairy cell leukaemia
Pressmeddelanden • Apr 03, 2018 08:03 CEST
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL).
Lokelma approved in the EU for the treatment of adults with hyperkalaemia
Pressmeddelanden • Mar 22, 2018 17:58 CET
Patients will benefit from Lokelma’s rapid reduction and sustained control of potassium levels in the blood4,5
Lokelma is a highly-selective, oral potassium-removing agent. The approval is supported by data from three double-blind, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months. In these trials, for patients receiving Lokelma the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline. Lokelma also demonstrated sustained potassium control for up to one year.4,5
The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common life-saving medications for heart failure (HF), such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood. To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued; this can, however, compromise cardio-renal outcomes and increase the risk of death.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, AstraZeneca, said: “The consequences of hyperkalaemia can be serious, even life-threatening, and can occur in patients either with chronic kidney disease or as a result of taking some medications for heart failure. Today’s approval of Lokelma addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalaemia.”
Lokelma is currently under separate regulatory review in the US, with a decision expected in the first half of 2018.
About Hyperkalaemia
The risk of hyperkalaemia increases significantly for patients with CKD and for those who take common medications for HF, such as RAAS inhibitors, which can increase potassium in the blood. Hyperkalaemia occurs in 23% to 47% of patients with CKD and/or HF, with an estimated 200 million and 38 million people, respectively, living with each condition worldwide. Hyperkalaemia may lead to cardiac arrest and death, with mortality being up to 30% in patients with severe hyperkalaemia, if not treated rapidly.
Lokelma is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly-selective potassium-removing agent. It is administered orally, is odourless, tasteless and stable at room temperature. It has been studied in three double-blind, placebo-controlled trials and in one 12-month open label clinical trial in patients with hyperkalaemia. The recommended starting dose of Lokelma is 10g, administered three times daily. Once normokalaemia (normal potassium levels in the blood) has been achieved, a maintenance dose of 5g once daily is recommended with possible titration up to 10g daily or down to 5g once every other day to maintain a normal potassium level.
About AstraZeneca in Cardiovascular, Renal & Metabolism
Cardiovascular and metabolic diseases are a main therapy area and a key growth platform for AstraZeneca, which is now called Cardiovascular, Renal & Metabolism (CVRM), following the addition of Lokelma to our portfolio of medicines.
By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of these diseases and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVRM health for millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
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References
1 Kosiborod M, Rasmussen HS, Lavin P, et al. ‘Effect of Sodium Zirconium Cyclosilicate on Potassium Lowering for 28 Days Among Outpatients With Hyperkalemia.’ JAMA. 2014. doi:10.1001/jama.2014.15688.
2 Packham D, Rasmussen HS, Lavin P, et al. ‘Sodium Zirconium Cyclosilicate in Hyperkalemia.’ New Engl J Med. 2015; 372:222-31. doi:10.1056/NEJMoa1411487.
3 Ash S, Bhupinder S, Lavin P, et al. ‘A phase 2 study on the treatment of hyperkalemia in
patients with chronic kidney disease suggests that the selective potassium trap, ZS-9, is safe and efficient.’ Kidney Int. 2015; 88:404-411. doi:10.1038/ki.2014.382.
4 National Kidney Foundation. ‘Clinical Update on Hyperkalemia." 2014. Accessed 5 January 2017. https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf.
5 Fishbane S, Pergola PE, Packham DK, et al. ‘Long-term Efficacy and Safety of Sodium Zirconium Cyclosilicate for Hyperkalemia: A 12-Month, Open-Label, Phase 3 Study’. Poster presentation at: American Society of Nephrology Kidney Week; November 2017; New Orleans, LA. TH-PO1112.
Om AstraZeneca
AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se
Michelle Werner ny marknadsbolagschef för AstraZeneca Nordic-Baltic
Pressmeddelanden • Mar 14, 2018 14:13 CET
AstraZeneca provides update on MYSTIC trial timeline
Pressmeddelanden • Mar 12, 2018 08:04 CET
AstraZeneca and MedImmune, today announced an updated timeline for the final analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab). Based on current predictions, the final analysis of overall survival (OS) is now expected in the second half of 2018 (previously anticipated in the first half).
New data from landmark CVD-REAL study of patients with type-2 diabetes confirms CV benefits associated with SGLT-2 inhibitors
Pressmeddelanden • Mar 11, 2018 21:51 CET
Real-world evidence study of more than 400,000 patients with type-2 diabetes, 74% of whom did not have a history of established cardiovascular disease, supports the association of CV benefits with use of Farxiga Latest analysis includes heart attack and stroke endpoints, longer follow-up period and six additional countries across Asia Pacific, the Middle East and North America
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Träffa oss nästa vecka @vetfest_gbg. Läs mer här. https://t.co/8EcyFZwjmx https://t.co/KgkVSRy7NE
18 Apr 13:34 @AstraZenecaSE
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AstraZenecas EVP Leon Wang med på mötet med statsministrarna Modi och Löfven i Stockholm där han presenterade nya i… https://t.co/sxgqRBu1rg
17 Apr 14:38 @AstraZenecaSE
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För oss finns det ett naturligt samband mellan en hållbar verksamhet, omfattande samhällsansvar och ambitiös miljöa… https://t.co/MSFkk6J5AB
17 Apr 13:57 @AstraZenecaSE
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Om AstraZeneca
Om AstraZeneca
AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och... Visa mer
AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se