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# FDA Accepts Chiesi’s Triple Combination Asthma Inhaler
- URL: https://www.fdaweb.com/fda-accepts-chiesis-triple-combination-asthma-inhaler/
- Published: 2025-10-15T12:00:00.000Z
- Updated: 2026-09-14T15:24:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160044

FDA has accepted for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults. The device combines beclomethasone dipropionate, an inhaled corticosteroid; formoterol fumarate, a long-acting beta-agonist; and glycopyrrolate, an anticholinergic, in a single pressurized metered-dose inhaler administered twice daily.

The submission is based on data from the TRIMARAN and TRIGGER Phase 3 studies, which together evaluated more than 2,500 patients with uncontrolled asthma. The double-blind, randomized, active-controlled trials assessed the safety and efficacy of the triple combination compared to standard therapies.