EMA Panel Backs Budesonide/Formoterol Hybrid for Asthma, COPD

Megan Brooks

January 31, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed the hybrid medicine budesonide/formoterol fumarate dihydrate (Teva Pharma B.V.) for the treatment of adults with asthma and chronic obstructive pulmonary disease (COPD).

The product is called Budesonide/Formoterol Teva Pharma B.V. It is a duplicate of DuoResp Spiromax (same active ingredients), which was approved in Europe in 2014, the EMA said in a statement.

Budesonide is an inhaled glucocorticosteroid and formoterol fumarate dihydrate is a selective long-acting inhaled beta-2 adrenoceptor agonist. Budesonide has anti-inflammatory activity in the airways and formoterol acts mainly on beta-2 adrenergic receptors on bronchial smooth muscle to produce relaxation and bronchodilation.

Budesonide/Formoterol Teva Pharma B.V. will be available as an inhalation powder in two strengths (160 μg budesonide with 4.5 μg formoterol fumarate dihydrate and 320 μg budesonide with 9 μg formoterol fumarate dihydrate).

The hybrid product is indicated in the regular treatment of adults with asthma who are not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta-2 adrenoceptor agonists; or in patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2 adrenoceptor agonists.

In COPD, the product is indicated for symptomatic treatment in patients with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Detailed recommendations for the use of Budesonide/Formoterol Teva Pharma B.V. will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

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