Home / FDA News / Boehringer Ingelheim Announces FDA and EMA Regulatory Submission for Nintedanib in Systemic Sclerosis Associated ILD

Boehringer Ingelheim Announces FDA and EMA Regulatory Submission for Nintedanib in Systemic Sclerosis Associated ILD

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF).

Systemic sclerosis, also known as scleroderma, is a rare disease characterised by thickening and scarring of connective tissue throughout the body.1,2 The disease can cause scarring of the skin, lungs (interstitial lung disease), heart and kidneys which can be debilitating and may become life-threatening.1,2 Approximately 25% of patients develop significant pulmonary involvement within three years of diagnosis.3 Lung involvement is the leading cause of death among people with systemic sclerosis.1

Dr. Susanne Stowasser, Associate Head of Respiratory Medicine at Boehringer Ingelheim said, “Systemic sclerosis associated interstitial lung disease has a devastating impact on those it affects – often women in the prime of their lives. Pulmonary fibrosis is a key driver of mortality in systemic sclerosis, and currently there are no approved treatments for SSc-ILD. Boehringer Ingelheim is pleased that we are able to take a step closer to potentially bringing an approved treatment for addressing the decline in lung function to patients with this rare condition.”

The regulatory submissions are part of Boehringer Ingelheim’s ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.

Clinical research results relating to nintedanib in SSc-ILD will be shared with the scientific community during the American Thoracic Society Congress (17-22 May).

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/FDA-and-EMA-regulatory-submission-nintedanib-in-SSc-ILD

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