Chiesi Group Receives EMA for Triple-Combination Therapy Asthma

Chiesi announced the European Commission has granted the marketing authorization for Chiesi extrafine triple therapy combination ICS/LABA/LAMA in a single inhaler, for the treatment of asthma. This follows the 2017 approval of this therapeutic option for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

The triple therapy is a combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP; inhaled corticosteroid), Formoterol fumarate (FF; long-acting β2 agonist) and Glycopyrronium (G; long-acting muscarinic antagonist). Chiesi triple therapy for asthma is the first extrafine triple combination able to reach and treat the whole bronchial tree, including small airways. Chiesi’s Modulite extrafine particle technology potentially facilitating coordination of inhalation.

The product is provided with a dose counter that allow patients to track and manage their treatment efficiently.

“This is the first step towards taking our triple therapy for COPD patients and providing the same treatment option for Asthma patients,” said Alessandro Chiesi, Chiesi Group Chief Commercial Officer. “Chiesi is committed to developing and delivering alternatives to aid patients in the management of their respiratory conditions and treatment. The European Commission approval brings us one step closer to providing uncontrolled asthma patients with new treatment options for their care, reducing exacerbations and potentially simplifying the use for patients thanks to a single inhaler triple therapy.”

Asthma is a chronic inflammatory disease affecting over 339 million people worldwide. According to GINA Report, people with uncontrolled asthma have poor symptom control and/or frequent exacerbations requiring oral corticosteroids or experience serious exacerbations requiring hospitalization.

In patients with uncontrolled asthma, Chiesi triple therapy has been shown to reduce exacerbations and improve lung function in comparison to ICS/LABA (Inhaled Corticosteroid / Long-acting beta-agonist).

The CHMP recommendation and the European Commission decision are based on the efficacy and safety data of 4 clinical studies involving close to 3,000 patients.