AstraZeneca's Symbicort Turbuhaler Approved by China's NMPA for Mild Asthma in Adults and Adolescents Aged 12+

January 26, 2021/BioValleyBIOON/--AstraZenecaRecently announced, Symbicort® Turbuhaler® (English brand name: Symbicort Turbuhaler, budesonide and formoterol fumarate dihydrate inhalation powder II 160 mcg/4.5 mcg) has received official approval from the China National Medical Products Administration (NMPA) for use in adults and adolescents aged 12 years and older with mildAsthmaAnti-inflammatory Remission Therapy for Patients.

It is worth mentioning that,Symbicort® Turbuhaler® is the first combination therapy approved in China for the treatment of mild asthma(referring to inhaled corticosteroid/long-acting β2-agonist [ICS/LABA] combination therapy),and will provide comprehensive management plans for patients with mild, moderate, and severe asthma.Previously, Symbicort® Turbuhaler® had been approved for moderate to severeAsthmaRemission and maintenance therapy.

Symbicort® Turbuhaler® (Budesonide and Formoterol Fumarate Inhalation Powder II) is the preferred inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination therapy for the treatment of asthma and chronic obstructive pulmonary disease (COPD) in China, and has been approved for initial treatment in patients with asthma of all severities to achieveAsthmaof full-process control.

As a fixed-dose combination of budesonide (ICS) and formoterol (LABA), Budesonide and Formoterol Fumarate Powder for Inhalation II has been approved in approximately 120 countries for the treatment of asthma or chronic obstructive pulmonary disease (COPD), and was launched in China in 2004. It is also the only medication included in both the World Health Organization (WHO) Model List of Essential Medicines (2019 Edition) and the National Essential Medicines List (2018 Edition).AsthmaTherapeutic Combination Formulation.

In China, there are over 48 million asthma patients, with those having mild asthma accounting for more than 75% of the total population, and the majority of them have not received timely and accurateDiagnosisand treatment. Studies have shown that up to 30%-40% of patients with mild asthma may experience severe acute exacerbations. To effectively control symptoms and reduce the risk of acute exacerbations, mildAsthmaEarly anti-inflammatory intervention is very important.

Asthma

This approval is based on the SYGMA studies (including SYGMA 1 and SYGMA 2) published in The New England Journal of Medicine. The study results confirmed that, for patients whose condition was not adequately controlled with as-needed short-acting inhaled bronchodilators (SABA) alone, as well as for those whose condition was controlled with low-dose inhaled corticosteroids or leukotriene receptor antagonists (LTRA) plus as-needed SABA, subsequent anti-inflammatory reliever therapy with Budesonide and Formoterol Fumarate Inhalation Powder II was superior to as-needed short-acting β2-agonist therapy in mildAsthmaMore effective.

Professor Zhou Xin, Vice Chairman of the 10th Committee of the Respiratory Branch of the Chinese Medical Association and academic leader of the Department of Respiratory Medicine at Shanghai General Hospital, stated: “Currently, mild asthma is showing an increasingly high incidence trend. However, due to the mild symptoms, it has not received sufficient attention. The approval of the new indication for Budesonide and Formoterol Fumarate Inhalation Powder II provides another treatment option for patients and doctors, meeting the needs of a wide range of patients with mild, moderate, and severeAsthmapatients' clinical needs.” (Bioon.com)

Original source: AstraZeneca