Medicines regulator approves UK’s first dual combination inhaler for mild asthma

AstraZeneca said the marketing authorisation meant its Symbicort Turbohaler 200/6 could be used by 2.7 million adults in the UK who live with mild asthma.
Adult female patient uses a Symbicort Turbohaler

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK’s first dual combination reliever inhaler for mild asthma.

AstraZeneca’s Symbicort Turbohaler 200/6 contains budesonide and formoterol, and has been granted marketing authorisation for patients aged 12 years and older.

A statement published by AstraZeneca on 23 March 2023 said that the inhaler could be used by “approximately 2.7 million adults in the UK who live with mild asthma”.

“Budesonide/formoterol 200/6 is the first and only dual combination treatment to be approved in the UK for mild asthma, where a high unmet clinical need exists,” the statement said, adding that the approval was based on data from clinical trials involving more than 9,500 patients.

In 2018, study results published in The New England Journal of Medicine concluded that an inhaled glucocorticoid plus a fast-acting beta-2-agonist, in the form of budesonide-formoterol, was superior to the short-acting beta agonist terbutaline for asthma symptom control and reducing the risk of asthma exacerbations in patients with mild asthma.

Symbicort Turbohaler 200/6 was already approved for moderate-to-severe asthma as both maintenance and maintenance and reliever therapy.

Commenting on the marketing authorisation, Laura Squire, chief healthcare quality and access officer at the MHRA, said: “[The approval] follows a careful review of the data, which showed that Symbicort is more effective than commonly used short-acting beta agonists like salbutamol when taken alone.

“With this authorisation, UK patients with mild asthma are the first in Europe to receive a licensed treatment that is endorsed as the preferred reliever by the Global Initiative for Asthma (GINA).”

GINA was launched in 1993 in collaboration with the World Health Organization, the National Heart, Lung and Blood Institute, and the National Institutes of Health in the United States to reduce asthma prevalence, morbidity and mortality.

Last updated
The Pharmaceutical Journal, PJ, March 2023, Vol 310, No 7971;310(7971)::DOI:10.1211/PJ.2023.1.179465

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