AstraZeneca’s mild combination asthma reliever approved in UK

AstraZeneca’s (AZ’s) Symbicort (budesonide/formoterol) Turbohaler 200/6 has been approved in the UK as the first and only combination reliever therapy for adults and adolescents aged 12 years and above with mild asthma, the company announced.

Asthma is a chronic, variable, inflammatory disease characterised by asthma attacks and symptoms including breathlessness and wheezing. The condition affects around eight million people in the UK, where deaths from asthma have increased by more than 26% in the last ten years.

Evidence shows that patients with mild asthma remain at risk of severe asthma attacks, often associated with frequent over-reliance on SABA inhalers. These do not address underlying airway inflammation, AZ explained, and for safety reasons are no longer recommended for use as monotherapy.

The Medicines and Healthcare products Regulatory Agency's (MHRA's) decision on Symbicort, which is already approved in the UK for patients with moderate to severe cases, was based on positive results from four clinical trials demonstrating the effectiveness of the therapy against standard of care.

Results from one trial demonstrated a 51% reduction in the rate of annual asthma exacerbations versus SABA treatment with albuterol as needed, while another showed a 64% lower annual severe exacerbation rate than SABA treatment as needed.

Ian Pavord, professor of respiratory medicine at the University of Oxford said: “In the UK, asthma attacks remain a major burden in patients diagnosed with mild asthma and these are driven by airway inflammation. Budesonide/formoterol 200/6 reliever therapy helps target airway inflammation and also delivers rapid, long-acting relaxation of the airway.

AZ estimates that approximately 2.65 million adults in the UK who live with mild cases of the condition could be eligible for Symbicort.

Ed Piper, medical and scientific affairs director at AZ UK, said the company was “delighted” with the MHRA’s decision, adding that the approval "recognises the clinical utility of budesonide/formoterol 200/6 as an important new treatment option for patients with mild asthma in the UK”.

The authorisation comes just days after AZ and MSD’s – known as Merck & Co in the US and Canada – Lynparza (olaparib) was approved by the MHRA as part of a combination therapy for certain prostate cancer patients.

Specifically, the PARP inhibitor is now authorised in combination with anti-androgen therapy Zytiga (abiraterone) and prednisone or prednisolone for adult patients with metastatic castration-resistant prostate cancer for whom chemotherapy is not clinically indicated.