European marketing authorization for Trimbow as asthma treatment

The European Commission has granted marketing authorization for Trimbow (beclomethasone/formoterol/glycopyrronium), an extrafine formulation triple fixed combination therapy in a single inhaler, as a maintenance treatment for adult asthma patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS), who experienced one or more asthma exacerbations in the previous year.

The application was filed by Italian family-owned drugmaker Chiesi Group, and the Commission’s approval follows a November 2020 positive recommendation by the European Medicines Agency’s advisory committee.

This follows the 2017 approval of this therapeutic option for the treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS/LABA, or a combination of a LABA/LAMA (long-acting muscarinic antagonist).