Chiesi Group receives the European marketing authorisation for Trimbow® (beclometasone dipropionate, formoterol fumarate, glycopyrronium) an extrafine formulation fixed triple combination therapy for the treatment of asthma

• Trimbow is the first extrafine formulation fixed triple combination therapy in a single inhaler to be approved for use in appropriate asthma patients.^1,2 This follows the 2017 approval of this therapeutic option for the treatment of appropriate moderate to severe chronic obstructive pulmonary disease (COPD) patients.^1-3
• The Marketing Authorisation approval is based on Committee for Medicinal Products for Human Uses’ positive opinion and European Commission approval on data obtained in four clinical studies involving close to 3000 patients.^4-6

Parma, Italy, February 1, 2021 – Chiesi, an international research-focused healthcare group (Chiesi Group), announces that the European Commission has granted the marketing authorisation for Trimbow (beclometasone/formoterol/glycopyrronium), an extrafine formulation triple fixed combination therapy in a single inhaler, as a maintenance treatment for adult asthma patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS), who experienced one or more asthma exacerbations in the previous year.^1,2 This follows the 2017 approval of this therapeutic option for the treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS/LABA, or a combination of a LABA/LAMA (long-acting muscarinic antagonist).³

Chiesi’s triple therapy is a combination of an ICS/LABA/LAMA that contains beclometasone dipropionate (ICS), formoterol fumarate (LABA) and glycopyrronium (LAMA).^1,2 For asthma, this is the first triple, extrafine formulation, combination inhaler with the ability to reach the whole bronchial tree, including both the large and the small airways.⁷ The inhaler also contains a dose counter that allows patients to track and manage their treatment.^1,2

“This is the first step towards taking our triple therapy for moderate to severe COPD patients and providing the same treatment option for appropriate asthma patients,” said Alessandro Chiesi, Chiesi Group Chief Commercial Officer. “Chiesi is committed to developing and delivering alternatives to aid patients in the management of their respiratory conditions and treatment. The European Commission’ approval brings us one step closer to providing uncontrolled adult asthma patients with a new treatment option for their care, reducing exacerbations and potentially simplifying the use for patients, thanks to a single inhaler triple therapy.”

Asthma is a chronic inflammatory disease affecting over 339 million people worldwide.⁸ According to GINA, people with uncontrolled asthma have poor symptom control and/or frequent exacerbations requiring oral corticosteroids or experience serious exacerbations requiring hospitalisation.⁹ 

In patients with uncontrolled asthma, Chiesi triple therapy has been shown to reduce exacerbations and improve lung function in comparison to ICS/LABA.^1,2 The CHMP recommendation and the European Commission decision are based on the efficacy and safety data of four clinical studies involving close to 3000 patients.^4-6

About Chiesi Group

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative therapeutic solutions in its three focus areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support specialty care and consumer-facing self-care). The Group’s Research and Development centre is based in Parma and works alongside 6 other important research and development hubs in France, the U.S., Canada, China, the UK, and Sweden to pursue its pre-clinical, clinical, and regulatory programmes. In 2018 Chiesi has changed its legal status to a Benefit Corporation, according to the law in Italy, USA and, more recently, in France, by incorporating common benefit objectives into its bylaws, to generate value for its business, for the society and the environment. Since 2019, Chiesi has been the world’s largest B Corp certified pharmaceutical group. B Corps are global leaders convinced to leverage business as a force for good. Moreover, as a Benefit Corporation, Chiesi Farmaceutici S.p.A. is required by law to report annually in a transparent way about its progress in achieving the common benefits objectives it has set forward. The Group is committed to becoming carbon neutral by the end of 2035.

About Chiesi triple therapy^1,2

Chiesi’s triple therapy is the first extrafine formulation, fixed triple combination, of beclometasone dipropionate (ICS) / formoterol fumarate (LABA) / glycopyrronium (LAMA). It will be available as twice a day pMDI (pressurised metered dose inhaler), licensed for maintenance treatment of asthma, in adult patients not adequately controlled with a maintenance combination of a LABA and a medium dose of ICS, and who experienced one or more asthma exacerbations in the previous year. Chiesi’s triple therapy is also approved in COPD as maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS/LABA, or a combination of a LABA/LAMA.

For a full list of side effects and information on dosage and administration, contraindications and other precautions, please refer to https://www.medicines.org.uk/emc/  for further information.

About Asthma¹⁰

Asthma is a common long-term condition that can affect people of all ages and causes inflammation in the airways.
5.4 million people in the UK are currently receiving treatment for asthma: 1.1 million children (1 in 11) and 4.3 million adults (1 in 12). Around 200,000 people in the UK have severe asthma, this is a debilitating form of the condition that does not respond to usual treatments and can cause people to be in and out of hospital. The direct and indirect costs of asthma to societies are substantial. The NHS spends around £1 billion a year treating and caring for people with asthma.

References

1. Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution SPC. Available at: https://www.medicines.org.uk/emc/product/761/smpc. Accessed: 29 January 2021.
2. Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution SPC (Northern Ireland). Available at: https://www.medicines.org.uk/emc/product/12025/smpc. Accessed: 29 January 2021
3. Trimbow, EMEA/H/C/004257, EMA marketing authorisation valid throughout the European Union, approved 17/07/2017. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/trimbow#authorisation-details-section. Accessed: 29 January 2021.
4. gov: Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA). Available at: https://www.clinicaltrials.gov/ct2/show/NCT02296411. Accessed: 29 January 2021.
5. gov: Triple in Asthma Dose Finding (Triskel). Available at: https://clinicaltrials.gov/ct2/show/NCT02127866. Accessed: 29 January 2021.
6. JC Virchow et al. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER), Lancet 2019;(394):1737-49.
7. Usmani et al., Journal of Aerosol Medicine and Pulmonary Drug Delivery 2020;(33):1-8.
8. WHO, Asthma Facts: https://www.who.int/news-room/fact-sheets/detail/asthma Accessed: 29 January 2021.
9. GINA, Difficult-to-treat & severe asthma in adolescent and adult patients, Diagnosis Management, A GINA Pocket Guide for Health Professionals, 2019. Available at: https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf. Accessed: 29 January 2021.
10. Asthma UK Facts: Available at: https://www.asthma.org.uk/about/media/facts-and-statistics/. Accessed: 29 January 2021.