SCOTTISH APPROVAL OF A NEW TREATMENT FOR PEOPLE WITH CHRONIC PULMONARY RESPIRATORY DISEASE (COPD) - FORMOTEROL FUMARATE DIHYDRATE/GLYCOPYRRONIUM BROMIDE/BUDESONIDE[i]

SCOTTISH APPROVAL OF A NEW TREATMENT FOR PEOPLE WITH CHRONIC PULMONARY RESPIRATORY DISEASE (COPD) - FORMOTEROL FUMARATE DIHYDRATE/GLYCOPYRRONIUM BROMIDE/BUDESONIDE[i]

Luton, UK, 08 February 2021 – AstraZeneca today announced that Trixeo^® Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is now accepted for use by the Scottish Medicines Consortium (SMC) as a new option for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (LAMA).The SMC is funding this new treatment in COPD patients whose forced expiratory volume in one second [FEV1] is less than 50%.¹

COPD is the name for a collection of lung diseases including chronic bronchitis, emphysema, and chronic obstructive airways disease. Patients with COPD are 85% more likely to develop anxiety disorders compared with healthy individuals, with devastating consequences for patients,  their caregivers, and may increase healthcare utilisation.[ii]

The disease affects about 3 million people in the UK, leading to 30,000 annual deaths and more than 129,000 new diagnoses annually in Scotland alone – in 2015 COPD was ranked the 4th most common cause of life lost in Scotland.[iii]^,[iv]^,[v]^,[vi]

Dr Chris Carlin, Consultant Respiratory Physician, NHS Greater Glasgow & Clyde: “There’s an unmet need for practice-changing medicines that can reduce the burden of respiratory diseases like COPD, both for patients and for the NHS.  COPD has a profound impact in Scotland which many people may not be aware of.  This SMC approval is really welcome news for Scottish patients.  It’s great that we’ll have an addition to our treatment options which can reduce COPD exacerbations and support our respiratory teams’ objective of re-orientating towards proactive preventative COPD management.”

Improving lung function, reducing exacerbations, and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.[vii] Even a single COPD exacerbation may be associated with a significant increase in the rate of decline in lung function,[viii] a significant deterioration in quality of life,[ix] and can significantly reduce life expectancy and increase the risk of mortality.[x]^,[xi]

Dr Alex de Giorgio-Miller, Vice President, Medical & Scientific Affairs, AstraZeneca UK said “A COPD exacerbation can cause deterioration of a patient’s lung function and increase the risk of hospitalisation, so preventing exacerbations and keeping patients out of hospital is a key priority for us in the UK right now. Trixeo Aerosphere has demonstrated clear benefits in reducing the risk of exacerbations in patients with moderate to severe COPD versus dual combination therapies. This news is therefore welcome recognition of the importance role Trixeo Aerosphere has to play in reducing the burden of exacerbations for both patients and the NHS.”

The acceptance was based on the results of from key Phase III trials, ETHOS and KRONOS as part of the ATHENA clinical trial programme for formoterol fumarate/glycopyrronium bromide/budesonide which included more than 15,500 patients globally across 11 trials.^11,[xii]