Please login to the form below

Not currently logged in

AstraZeneca’s mild combination asthma reliever approved in UK

Over two and a half million adults with mild cases of asthma could be eligible for the treatment


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.

Article by
Emily Kimber

28th March 2023

From: Regulatory



Subscribe to our email news alerts


Add my company

We are a leading provider of outsourced commercial, medical and recruitment services to UK pharmaceutical, biotech and healthcare companies....

Latest intelligence

Whitepaper: Closing the gap with compelling healthcare communications
Want to learn how to close the distance between a person’s current health and their healthiest possible self?...
Healing the Healers
Because if we do not heal the healers, who is going to heal us?...
The (inevitable) digital transformation of Medical Affairs
It’s not a question of ‘if,’ it’s a question of ‘when.’...