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Chiesi Farmaceutici is the first company to submit a marketing authorisation application to the European Medicine Agency for a Triple Combination for the treatment of COPD

Date: 29/09/2016

Parma, September 29, 2016 - Chiesi Farmaceutici SpA (Chiesi) announces today the submission to the European Medicines Agency (EMA) of the marketing authorisation application for the first ICS/LABA/LAMA triple combination. The product is indicated for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and is administered by using one single inhaler, specifically formulated by Chiesi to deliver extra-fine particles efficiently (reaching both central and peripheral airways).

“We are proud of this key milestone in our R&D programme. If approved, this therapeutic option will, on one hand, mark genuine progress in the management of COPD patients, to reduce the impact of their pathological condition, both on their health and on their quality of life. On the other hand, its clinical outcome will reduce the direct and indirect costs associated with patient hospitalisation”, says Paolo Chiesi, Vice President and R&D Director of Chiesi Farmaceutici.

The submission of the dossier is based on the results of a large and comprehensive development program performed by Chiesi started in 2009, which included 12 clinical studies involving more than 8,000 patients. In particular:

  • TRILOGY[1] study, published by The Lancet, provided for the first time evidence that the extra-fine fixed ICS/LABA/LAMA triple combination is superior to the fixed dose ICS/LABA combined therapy (one of the standard treatments for this condition) regarding a series of clinical efficacy parameters, and demonstrates good safety profile.
  • TRINITY[2], a second pivotal clinical trial, has proven the superiority of the extrafine fixed ICS/LABA/LAMA combination also compared to the LAMA tiotropium, another standard therapy for COPD.

Patients with COPD have unmet therapeutic needs, such as reducing the risk of exacerbations that impair the quality of life, lead to hospitalisation and that may even be life-threatening. This requires patients to be treated with multiple treatments taken through different inhaler devices. Therefore, the possibility of taking all drugs needed, reaching both central and peripheral airways by using one single inhaler, simplifies the treatment of COPD patients considerably.

 

About Chiesi Farmaceutici

Headquartered in Parma, Italy Chiesi Farmaceutici is an international research-focused Healthcare group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare diseases areas. Its R&D centres in Parma (Italy), Paris (France), Cary (USA), Chippenham (UK) and the R&D team of the acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs over 4,500 people, 560 of whom are solely dedicated to R&D activities. For more information, please visit www.chiesi.com

 

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.

 

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Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "seeking," "believe," "will," "believes," "committed," "growing," "plans," "well-positioned," or similar terms, or by express or implied discussions regarding potential marketing approval for the Chiesi triple fixed dose combination. Such forward-looking statements reflect the current views of Chiesi regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results expressed or implied by such statements. There can be no guarantee that the Chiesi triple fixed dose combination will be approved for sale in any market, or at any particular time. Neither can there be any guarantee that, if approved, the Chiesi triple fixed dose combination will be approved for all indications included in the reference product's label. In particular, management's expectations regarding the Chiesi triple fixed dose combination could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally.

 

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Media Contacts:

Valentina Biagini

Chiesi Group Communication Manager

Ph. +39 348 7693 623

v.biagini@chiesi.com

 

[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] Singh D, Corradi M, Montagna I, Cohuet G, Francisco C, Vezzoli S, Muraro A, Petruzzelli S, Scuri M, and Vestbo J. TRINITY: A phase III study to compare the efficacy and safety of an extrafine triple combination of beclometasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium bromide (GB) pMDI (CHF5993) with tiotropium (Tio) and a free triple combination of BDP/FF (Foster®) + Tio in COPD patients.