Drugs Controller General (India) approves Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD)

  • Approval is based on the SENSCIS® study which showed Nintedanib slows the loss of pulmonary function in people living with systemic sclerosis-associated ILD (SSc-ILD)  
  • Following the FDA’s approval in September 2019, Nintedanib in SSc-ILD has so far been approved in 15 countries including European Union, Canada, Japan and Brazil
  • Being the first and only approved treatment option available for people living with SSc-ILD, the approval constitutes a breakthrough in an area of high unmet need
     

Mumbai, May 20, 2020 – Boehringer Ingelheim (India) announced that the DCGI has approved Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults. The approval comes after the Subject Expert Committee (CDSCO) had adopted a positive opinion for Nintedanib in treatment of SSc-ILD on 3rd March 2020.

Systemic sclerosis (SSc), also known as scleroderma, is a disfiguring, disabling and potentially fatal rare autoimmune disease.ii iii iv It causes scarring (fibrosis) of various organs, including the lungs, heart, digestive tract and kidneys and can lead to life-threatening complications. When the lungs are affected, it can cause interstitial lung disease (ILD), known as SSc-ILD1,v. ILD is a leading cause of mortality, accounting for almost 35% of SSc-related deaths.Vi

“Systemic sclerosis is a life- altering condition and Nintedanib is the first and only approved treatment for SSc-ILD, serving a high unmet need making a real positive difference. For the treatment of people living with SSc-ILD, this is a quantum leap” said Sharad Tyagi, MD, Boehringer Ingelheim India. “The DCGI approval is a milestone in Boehringer Ingelheim’s dedication towards providing the best possible treatment for people living with SSc-ILD in India.” he added.

DCGI’s approval is based on the results of the SENSCIS® trial, a Phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of Nintedanib in patients with SSc-ILD.1 The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC) assessed over a 52-week period. Results showed Nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks.1 Furthermore, results showed that Nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF).1

Regulatory approvals for the treatment of patients living with SSc-ILD have also been granted in several countries including EU, Canada, Japan and Brazil. Nintedanib is approved in over 75 countries for the treatment of IPF, and it is the first approved treatment for SSc-ILD.vii

~ENDS~

Notes to Editors

SENSCIS® Trial
SENSCIS® was the largest randomised controlled trial to be conducted in patients with SSc-ILD, involving 576 patients across more than 32 countries including the United States, Canada, China, Japan, Germany, France, India and the United Kingdom. The primary endpoint was the annual rate of decline in lung function as measured in FVC (mL/year) assessed over 52 weeks. The trial also collected data on other manifestations of the disease with key secondary endpoints identified as skin thickness as measured by absolute changes from baseline in modified Rodnan skin score (mRSS) and health-related quality of life measured by the total score on the St George’s Respiratory Questionnaire (SGRQ) at week 52. Enrolment criteria included a diagnosis of SSc with onset of first non-Raynaud symptoms within 7 years, ILD confirmed by high resolution computed tomographic that showed fibrosis affecting at least 10% of the lungs, at least 40% predicted FVC, and a diffusion capacity of the lung for carbon monoxide (DLco) as 30–89% predicted. Patients were randomised to receive Nintedanib 150 mg twice daily or placebo. Patients on stable therapy with mycophenolate or methotrexate and/or taking prednisone up to 10 mg/day were allowed to participate.1
 

About systemic sclerosis-associated ILD
Systemic sclerosis-associated ILD is a chronic lung disease in which scar tissue (“fibrosis”) and/or inflammation builds up in the walls of the air sacs of the lungs in a person with a diagnosis of scleroderma.viii ILD is the leading cause of mortality in SSc, responsible for up to 35% of SSc-related deaths.7 The onset of SSc typically occurs at a young age, between 25 and 55 years, and ILD can develop early in patients with SSc, so regular screening is critical.6,viii,ix
 

Nintedanib
Nintedanib is a tyrosine kinase inhibitor targeting key receptors involved in signalling pathways that lead to pulmonary fibrosis.x It is already approved in more than 75 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – a chronic and ultimately fatal disease characterised by a decline in lung function. It is estimated that over 80,000 people with IPF have been treated with Nintedanib, and it is recommended for use in IPF patients by international guidelines.xi

In September 2019, Nintedanib was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD8. Submissions have been made to other regulatory bodies across the globe and so far, regulatory approvals have been granted in EU, Canada, Japan, Brazil and other countries.

Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

Since its inception in 2006, Boehringer Ingelheim in India has seen a phenomenal growth trajectory aided by the launches of innovator products like Pradaxa, Trajenta, Actilyse, Giotrif (local brand name Xovoltib), Ofev (local brand name Cyendiv), Glyxambi and Jardiance. Our business units are based on the therapy areas being catered to – 1) Diabetes and 2) Speciality (Giotrif, Ofev, Actilyse and Pradaxa). Boehringer Ingelheim India ranks 8th amongst the pharma multinational companies.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Intended audiences
This press release is issued from our India Headquarters in Mumbai, and is intended to provide information about our India business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

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ii Denton CP, Khanna D. Systemic sclerosis. Lancet 2017; 390:1685–99.
iii Cottin V, et al. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respir Res 2019;20:13.
ivKowal-Bielecka O, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis 2017; 76:1327–1339.
vSolomon JJ, et al. European Respiratory Update: Scleroderma lung disease. Eur. Respir. Rev. 2013; 22: 127, 6–19.
viTyndall AJ, et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis 2010; 69:1809–1815.
viiUS Food and Drug Administration. Press release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease. Last accessed April 2020.
viiiPulmonary Fibrosis Foundation. Scleroderma-associated interstitial lung disease (SSc-ILD). Available at: https://www.pulmonaryfibrosis.org/docs/default-source/disease-education-brochures/pf-fact-sheet-series---ssc-ild_digital.pdf?sfvrsn=ae99918d_2. Last accessed April 2020.
ixScleroderma Foundation. What is scleroderma? Available at: http://www.scleroderma.org/site/PageNavigator/patients_whatis.html#.V%20hgSaPlViko. Last accessed April 2020.
xJaeger VK, Wirz EG, Allanore Y, et al. Incidences and risk factors of organ manifestations in the early course of systemic sclerosis: a longitudinal EUSTAR study. PLoS One. 2016; 11(10):e0163894.
xiOfev Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/ofev-epar-product-information_en.pdf (Date of latest renewal: 23 September 2019). Last accessed April 2020.
xiiRaghu G, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis: Executive Summary. Am J Respir Crit Care Med. 2015; 192(2)238 – 248.