Chiesi Group receives the European Marketing Authorisation for Trimbow® (ICS/LABA/LAMA)

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Date: 24/07/2017

Chiesi Group (Chiesi), an international research-focused healthcare company, today announced that the European Commission has granted the marketing authorisation for Trimbow® for the treatment of Chronic Obstructive Pulmonary Disease (COPD) in adult patients. As a result, Trimbow® is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).


Trimbow® is a combination of an Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) containing Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium bromide (GB), administered as a fixed dose twice daily in a pressurised Metered Dose Inhaler (pMDI) extrafine formulation.

“The marketing authorisation of Trimbow® in the EU is a significant treatment advance for COPD patients and reinforces the Chiesi Group’s leadership in the respiratory arena.” comments Alessandro Chiesi, Region Europe Head, Chiesi Group. “Trimbow® is the first approved fixed triple combination therapy in a single inhaler for the treatment of COPD, a pathology that involves also the small airways. The use of one inhaler should simplify the intake of the therapy and therefore may improve adherence. We aim to make available this product to patients as soon as possible.”


Two of the 12 clinical studies on Trimbow® involving over 7000 patients, were recently published on The Lancet — one of the most prestigious international medical journals:
• TRILOGY1 is the study published in the special European Respiratory Society (ERS) edition of The Lancet and presented at the 2016 ERS Congress in London. The study provided, for the first time, one-year evidence that the extrafine fixed ICS/LABA/LAMA triple combination Trimbow® is superior to a fixed dose ICS/LABA therapy (one of the standard treatments for COPD) on a number of clinical parameters, including exacerbations, and demonstrates a comparable safety profile.
• TRINITY2, published on the Lancet online issue of April 3, 2017, is the study demonstrating for the first time the superiority of Trimbow®, compared to a LAMA (Tiotropium), another standard treatment for COPD, again on a number of efficacy parameters including exacerbations.


For the EU Summary of Product Characteristics for Trimbow®, please visit http://ec.europa.eu/health/documents/community-register/html/newproc.htm


About COPD
COPD is a respiratory disease characterized by a persistent bronchial obstruction, associated with an increased chronic inflammatory response of the airways to noxious particles or gas. The classic symptoms associated with COPD are dyspnoea, chronic cough and chronic productive sputum. In some cases, an acute worsening of the above-mentioned symptoms may occur, triggering an exacerbation. A double mechanism is at work in the bronchial obstruction in COPD patients: on one hand, an inflammation of the small airways together with the thickening of the airways walls and increased airflow resistance may occur. On the other, a progressive destruction of lung parenchyma (emphysema) associated with the loss of elastic retraction of the lung may take place. It is important to underline that both mechanisms may coexist, leading to a significant airflow reduction throughout the lungs.


About Trimbow®
Trimbow® is the first extrafine fixed triple combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / Long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate **PRESS RELEASE**
(BDP), Formoterol fumarate (FF) and Glycopyrronium bromide (GB). Trimbow® will be available as pMDI (pressurized metered dose inhaler) to be marketed with an approved indication for 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.


About Chiesi Group
Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused Healthcare Group, with over 80 years of experience in the pharmaceutical industry, present in 26 countries. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and integrated with 6 other key R&D groups in France, the USA, the UK, Sweden and Denmark to advance Chiesi's pre-clinical, clinical and registration programmes. Chiesi employs nearly 5,000 people.


References
1 Singh D, Papi A, Corradi M, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, and Vestbo J.. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2 agonist for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Accepted (2016) THELANCET-D-16-04974R1, S0140-6736(16)31354-X
2 Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. www.thelancet.com Published online April 3, 2017 http://dx.doi.org/10.1016/S0140-6736(17)30567-6About Chiesi Farmaceutici (Arial, pt 9) Chiesi Farmaceutici is a research-focused international group, with more than 75 years of experience headquartered in Parma (Italy). Chiesi researches, develops and commercializes innovative pharmaceutical solutions in the respiratory therapeutics and specialist medicine areas. In 2013, Chiesi achieved sales of over 1.2 billion Euros, constituting double digit growth over 2012. Its R&D centers in Parma (Italy), Paris (France), Rockville (USA), Chippenham (UK) and the R&D team of the newly-acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi Group employs approximately 3900 people, 480 of which are dedicated to R&D activities.
For more information, please visit www.chiesi.com