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The first drug for inhalation in triple extrafine combination arrives in Brazil



  pharmaceutical chiesi

The National Health Surveillance Agency (Anvisa) has approved registration of Trimbow® for the treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is the world's first unitary triple combination with a unit device, now approved in Brazil, and will be available to patients in the coming months.

The combination gathers in one unit three active substances: dipropionate beclometasone, an anti-inflammatory class in the inhaled corticosteroid (IC); and two bronchodilators – formoterol fumarate, a long-acting beta-2 agonist (LABA) and glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA). Trimbow® is formulated in a Modulite® technology solution in a pressure-measured inhaler (pMDI), which produces an inhalation mist consisting of extra fine particles, with optimized peripheral lung deposition and extended small airway area 2 first place for development of KOL .

Triple therapy is included in national recommendations1

and also in the international GOLD2 guideline for the treatment of COPD. But until now, in Brazil, triple therapy was only possible with two separate units. Trimbow® provides significant advances in the treatment of COPD patients by allowing the administration of three drugs in a single unit, with greater dose comfort and increasing superior clinical benefits compared to currently available therapies 3.4 and 5 . The use of a single inhaler should simplify the administration of therapy and therefore may improve patient compliance and, consequently, their clinical condition.

The development of Trimbow® involved more than 7,000 patients in 12 clinical trials, and the most important positive superiority and safety results have been published sequentially in recent years in The Lancet, one of the most prestigious international medical journals:

  • TRILOGY³ was the first study published in the world on triple therapy in a single inhaler (2016), IC / LABA / LAMA extrafine triple-fixed combination, Trimbow®, and for the first time gave evidence of superiority over therapy. dose of IC / LABA (one of the standard COPD therapies) in a range of clinical parameters, including strengthening lung function and reducing exacerbations.
  • TRINITY⁴, published in 2017, first showed the superiority of the extra-fine triple combination compared to a LAMA (tiotropium), another standard for
    treatment for COPD, again in several efficacy parameters, including greater reduction of annual deterioration and improved quality of life.
  • TRIBUTE⁵, published in 2018, also showed the superiority of Trimbow® over a fixed combination of two LABA / LAMA bronchodilators (indacaterol / glycopyrronium), which evaluated the degree of moderate to severe exacerbation for one year in patients with COPD.

The clinical development program Trimbow® provided robust superiority data on all primary clinical outcomes defined in the studies, such as lung function enhancement. and, in particular, the reduction of exacerbations, which ensure their efficacy and safety over existing pharmacological classes currently used in the treatment of the disease3,4 and 5. COPD exacerbation is defined as an exacerbation of respiratory symptoms requiring treatment with systemic corticosteroids, antibiotics or hospital stay or any combination thereof5. . Serious exacerbations are those that require hospitalization or lead to death5.

The GOLD International Guideline (2019) considers that exacerbations are important events in the treatment of COPD as they adversely affect health status, hospital stay and readmission rate and disease progression2. It is well established that COPD aggravation contributes to the development of the disease, and as a COPD patient experiences an exacerbation, it will trigger increased sensitivity and less time for another event, which further emphasizes the importance of preventing it. Exacerbations also accelerate the progressive decline in lung function and their frequency is now recognized as an important component in the characterization of COPD patients. Therefore, prevention and treatment of COPD (especially moderate and severe exacerbations) has become the main focus for healthcare professionals.

Trimbow® is manufactured and marketed by Chiesi Pharmaceuticals and will be available on the Brazilian market in the coming months.

About Trimbow®

Trimbow® is the first triple combination fixed dose in inhaled extra-fine corticosteroid (IC) formulation, long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA) – becmetomethone dipropionate, formoterol fumarium bromide and glycopyrronium bromide. Trimbow® will be available in a dosed dose-based inhaler (pMDI) with approved maintenance therapy in adult patients with chronic obstructive pulmonary disease (COPD) who are not adequately treated with a combination of an inhaled corticosteroid and a long-acting beta-2 agonist.

About COPD

Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death worldwide8, but is estimated to be the third leading cause of death by 2020. More than 3 million people died of COPD in 2012, accounting for 6%. of all deaths worldwide. COPD represents an important public health challenge, which is preventable and treatable
. COPD is a leading cause of chronic morbidity and mortality worldwide; Many die prematurely of it or the complications. Overall, COPD prevalence is expected to increase over the coming decades, mainly due to continued exposure to risk factors such as smoking and pollution, in addition to the aging of the population9.

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease characterized by persistent bronchial obstruction associated with increased chronic airway inflammation in response to harmful particles and gases. Classical symptoms of COPD include dyspnea, chronic cough and chronic productive sputum. In some cases, an acute exacerbation of the aforementioned symptoms may occur and trigger an exacerbation. A dual mechanism works in chronic obstruction in COPD patients: On the one hand, small airway inflammation may occur along with thickening of the airway walls and increased resistance to airflow. On the other hand, there may be progressive destruction of pulmonary parenchyma (emphysema) associated with loss of elastic lung invasion. It is important that both mechanisms can coexist, leading to a significant reduction in airflow through the lung.

About the Chiesi Group

Headquartered in Parma, Italy, Chiesi Pharmaceuticals is an international healthcare-focused research group with over 80 years of industry experience in 27 countries. Chiesi develops and markets innovative medicines in the respiratory treatment line, specialty medicine and rare diseases. With its main R&D center based in Parma, Italy, Chiesi is integrated with six other R&D groups in France, the United States, the United Kingdom and Sweden and is developing in preclinical, clinical and patient registration programs. new therapies. Chiesi has approximately 5,700 employees and is certified as a Benefit® Corporation.

References

first Fernandes FLA, Cukier A, Camelier AA, Fritscher CC, CHD Coast, EDB Pereira, Godoy I, JED Footpath, Romaldini JG, Chatkin JM, JR Garden, Rabahi MF, Nucci MCNM, Sales MDPU, Castellano MVCO, Aidé MA, Teixeira PJZ , Maciel R, Correa RA, Stirbulov R, Athanazio RA, Russian R, Minamoto ST, Lundgren FLC. J Bras Pneumol. 2017; 43 (4): 290-301.

2nd Global initiative for obstructive pulmonary disease (GOLD). https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf [acesso em 25 de Outubro de 2019].

3rd Singh D, Papi A, Corradi M, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M and Vestbo J. Triple therapy with a single inhaler versus inhaled corticosteroid plus long-acting p2 agonist for chronic obstructive pulmonary disease (TRILOGY): a double blind , parallel group, randomized controlled trial. Lancet. 2016; 3, 388 (10048): 963-73.

4th Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, et al. Single-inhaler extra-fine triple therapy versus long-acting muscarinic antagonist therapy in chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomized controlled trial. Lancet. 2017; 389 (10082): 1919-1929.

5th Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, Guasconi A, Montagna I, Vezzoli S, Petruzzelli S, Scuri M, Roche N, Singh D. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease treatment (TRIBUTE): a double-blind, parallel group, randomized controlled trial. Lancet. 2018; 391 (10125): 1076-1084.

6th Celli B.R. and Barnes P.J., exacerbations of chronic obstructive pulmonary disease. Eur Respir J. 2007; 29: 1224-1238.

7th Wilke S. et al., One year's change in health status and subsequent results in COPD. Thorax. 2015; 70: 420-5.

8th Eerd EA, der Meer RM, Schayck OC, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016; (8): CD010744.

ninth Frazer K, Callinan JE, McHugh J, et al. Legislative smoking ban to reduce damage from exposure to smokers, smoking prevalence and tobacco consumption. Cochrane Database Syst Rev 2016; 2: Cd005992.

        
        
        
        


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