Progress for AstraZeneca on cardiovascular, COPD and lung cancer drugs
A number of advances for AstraZeneca’s drugs have been confirmed.
Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults with and without type-2 diabetes (T2D).
John McMurray, of the Cardiovascular Research Centre at the Institute of Cardiovascular and Medical Sciences, University of Glasgow, said: “I am delighted that we may soon have a new treatment that is effective, safe and simple to use for patients with heart failure with reduced ejection fraction.
“Dapagliflozin is a major and welcome breakthrough with the potential to improve not only the quality, but also importantly, the length of life for millions of people suffering from this terrible disease in Europe and throughout the world.”
Sir Mene Pangalos , executive vice president, biopharmaceuticals R&D at AstraZeneca, said: “The unmet need for novel medicines in heart failure remains high, with more than half of patients expected to die within five years of diagnosis.
“Novel treatment options reducing cardiovascular death and hospitalisation, in addition to improving symptoms, are urgently needed. With the positive opinion for Forxiga we are one step closer to transforming the standard of care for millions of people in the EU living with heart failure.”
Triple combination therapy Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been recommended for marketing authorisation in the EU for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD), where other treatments have not proved effective.
Dr Pangalos said: “Chronic obstructive pulmonary disease is now the third leading cause of death globally and affects approximately one in 10 adults over the age of 40 in Europe.
“Trixeo Aerosphere has demonstrated strong clinical benefit when compared with dual-combination therapies and this positive recommendation brings us closer to providing a much-needed new treatment to patients in Europe.”
Meanwhile, Tagrisso (osimertinib) has been accepted for a supplemental New Drug Application (sNDA) and granted priority review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
Dave Fredrickson, executive vice president, oncology business unit, said: “Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients.
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