AstraZeneca submits Atacand for approval in Europe for use in heart failure treatment
Written on March 19, 2010 – 12:57 pm | by gabonshort
AstraZeneca submits regulatory request in Europe as a service to the use of Atacand in the treatment of heart deficiency.
Results of landmark CHARM reflect on programme conduct the basis of heart failure docility for unrivalled hypertension treatment, Atacand
AstraZeneca today announced the capitulation of a regulatory solicitation in the European Splice (EU), as enter in of the Mutual Recognition Variation Procedure to obtain a new indication for Atacand (candesartan cilexetil), its angiotensin II quintessence 1 (AT1) receptor blocker, instead of detest in the treatment of heart failing (CHF).
The timidity has been made in the UK as part of the Mutual Detection Activity. Further filings in the US and other markets are expected in the near approaching.
This submission follows the positive results of the CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity) Programme, first presented at the European Sisterhood of Cardiology (ESC) in August 2003. CHARM proved Atacand as the first AT1-receptor blocker, to mitigate both cardiovascular deaths as well as hospital admissions, across a broad spectrum of patients with chronic heart crash.
Additional analyses of the CHARM data, presented at the ACC (American College of Cardiology Union, New Orleans, 7-10 March), added further evidence during the benefits of Atacand in CHF. One division found that also New York Verve Association (NYHA) functional class improved in a ungentlemanly spectrum of CHF patients treated with Atacand.
Dr Gunnar Olsson, Vice-President and Principal of the Cardiovascular Therapy Area, said: “Heart dereliction remains a surely serious, costly condition and there is hushed a real fundamental in the interest of additional, effective therapies. It is a crucial create of death, hospital admissions and self-reported quality of passion is impaired more by CHF than by any other common chronic medical shambles.
AstraZeneca is delighted that CHARM has shown that Atacand can benefit a broad range of heart bankruptcy patients. This dossier submission is a start further near Atacand becoming at one’s disposal to doctors as a new and effective treatment recourse, offering more benefits to patients both in terms of healthier outcomes, including improved symptom call the tune, reduced mortality, better quality of life, and heartier tolerability.”
Atacand is an angiotensin II type 1 (AT1) receptor blocker indicated for the treatment of high blood pressure. As a proven and leading antihypertension therapy, Atacand was anything else licensed in 1997 and has been shown to lower blood straits more effectively than losartan, the initially introduced AT1-receptor blocker.
Fresh clinical outcome studies with Atacand, SCOPE and CHARM, accept demonstrated the clinical value of the panacea in hypertension and heart failure, strengthening the position of Atacand as the premier AT1-receptor blocker in its bearing. In 2003, Atacand’s worldwide sales were $750m, a 32 per cent increase on the earlier year.
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Notes to hearsay editors:
· AstraZeneca is a major international healthcare business promised in the analysis, maturity, manufacture and marketing of prescription pharmaceuticals and the come up with of healthcare services. It is one of the top five pharmaceutical companies in the society with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Hint (Global and European) as well as the FTSE4Good Index finger. AstraZeneca has more than 40 years’ affair in cardiovascular prescription and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and brunt of cardiovascular disease. AstraZeneca has a encompassing cardiovascular portfolio including CRESTOR™, Atacand™, ZESTRIL™, TENORMIN™, SELOKEN® ZOK /TOPROL-XL™ and Plendil™. This heritage is complemented by an innovative hose including the first oral direct thrombin inhibitor, Exanta™, and a romance treatment in the interest font 2 diabetes / metabolic syndrome, GALIDA™.
· Candesartan Cilexetil is marketed by AstraZeneca under trademark Atacand®. Atacand® is manufactured under ahead from Takeda Chemical Industries Ltd.
· AstraZeneca is the developer and sole sponsor of the CHARM calendar. The OVERCOME Programme, which recruited 7,601 patients, is the largest-ever trial programme conducted in heart folding with an AT1-receptor blocker. Patients were randomised to either Atacand® or placebo in a 1:1 correspondence in each of the three component studies. The GRACE results showed that Atacand is the first Angiotensin Receptor Blocker (ARB) to increase survival in chronic heart folding patients with left ventricular dysfunction, whether or not they are alluring an ACE-inhibitor. In patients who were not winsome ACE-inhibitors straight membership fee to previous intolerance, Atacand significantly reduced the risk of cardiovascular death or hospitalisation for chronic consideration breakdown, the relative risk reduction being 23 per cent (p
