Trixeo Aerosphere Approved in Scotland as COPD Maintenance Therapy
The approval specifically covers adults with moderate to severe disease who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), or by a LABA used in conjunction with a long-acting muscarinic antagonist (LAMA).
Funding from the SMC will cover the costs of the newly approved treatment in people with COPD whose forced expiratory volume in one second (FEV1) is less than 50%. FEV1 is a measurement of lung function.
“This SMC approval is really welcome news for Scottish patients,” Chris Carlin, PhD, consultant respiratory physician at National Health Service (NHS) Greater Glasgow and Clyde, said in a press release.
“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,” Carlin said.
Carlin added that COPD “has a profound impact in Scotland which many people may not be aware of.” In Scotland, about 129,000 people are diagnosed with COPD every year; COPD was the fourth most common cause of death in the country in 2015.
Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is a triple combination therapy containing the corticosteroid budesonide and two types of bronchodilators: glycopyrronium (a LAMA) and formoterol fumarate (a LABA). Bronchodilators are medications that widen and relax the airways in the lungs, making it easier for air to flow through them.
The therapy is administered via an inhaler and it is meant to reduce the frequency and severity of COPD exacerbations (episodes when symptoms suddenly worsen).
These approvals were based on the results of the Phase 3 clinical trials ETHOS (NCT02465567) and KRONOS (NCT02497001). The studies compared Trixeo Aerosphere with two dual-combination therapies made by AstraZeneca: Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and Symbicort (budesonide/formoterol fumarate).
Results demonstrated that Trixeo Aerosphere more effectively reduced the frequency of COPD exacerbations than the dual combination therapies. Safety profiles were similar among the triple- and dual-combination therapies.
“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,” said Alex de Giorgio-Miller, PhD, vice president, medical and scientific affairs, AstraZeneca U.K.
“Trixeo Aerosphere has demonstrated clear benefits in reducing the risk of exacerbations in patients with moderate to severe COPD versus dual combination therapies,” de Giorgio-Miller said.
The SMC approval “is therefore welcome recognition” of Trixeo Aerosphere’s role “in reducing the burden of exacerbations for both patients and the NHS,” de Giorgio-Miller added.