Chiesi Group Receives European Marketing Authorization for Trimbow® Inhalation Powder

Chiesi, an international research-focused healthcare group has announced that the European Commission has granted the marketing authorization for Trimbow® inhalation powder delivered through NEXThaler (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium), an extrafine formulation triple fixed combination therapy in a single dry powder inhaler (DPI), for the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.

Chiesi’s triple therapy in a pressurized metered dose inhaler (pMDI) formulation was previously approved in 2017 and with this new authorization, COPD patients for whom a DPI is preferred may now benefit from this therapeutic option in a NEXThaler device. It is extremely important to have both options available for different patients’ needs as pMDIs and DPIs are the most commonly used devices for patients with chronic respiratory diseases such as COPD. Tailoring inhaler choice to a patient’s ability to use specific devices, coupled with ongoing education to support optimal inhaler usage, may improve patient confidence and enhance both adherence and disease control.

“With the marketing authorization for our triple therapy in a NEXThaler device in the EU, the Chiesi Group reinforces its commitment to providing a broad portfolio of formulations and devices to COPD patients and physicians.” comments Alessandro Chiesi, Chief Commercial Officer, Chiesi Group. “Chiesi triple therapy is today the first and only triple fixed combination treatment providing both pMDI and DPI devices as options for patients and physicians. We aim to make this treatment available to appropriate patients in Europe as soon as possible.”

Chiesi’s triple therapy in a NEXThaler device was approved in EU based on the TRI-D study which found similar efficacy and safety to the pMDI formulation in patients with moderate to severe COPD. Data from the TRILOGY, TRINITY and TRIBUTE clinical trials have already established that Chiesi’s triple therapy in a pMDI formulation is an efficacious and well-tolerated treatment for moderate to severe COPD.

The NEXThaler device is equipped with a counter for the inhalations. The number of inhalations shown in the window on the device does not decrease on closing the cover if the patient has not inhaled through the inhaler, which potentially helps them track and manage their treatment. NEXThaler is a device with a breath-activated mechanism (BAM) which allows the dose to be fully delivered when the optimal inspiratory flow rate is reached.