Research & Development
Boehringer Ingelheim Files FDA and EMA Regulatory Submission for Nintedanib in Systemic Sclerosis Associated ILD
21 March 2019 - - German drugmaker 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, the company said.

Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis.

Systemic sclerosis, also known as scleroderma, is a rare disease characterised by thickening and scarring of connective tissue throughout the body.

The disease can cause scarring of the skin, lungs (interstitial lung disease), heart and kidneys which can be debilitating and may become life-threatening.

Approximately 25% of patients develop significant pulmonary involvement within three years of diagnosis.

Lung involvement is the leading cause of death among people with systemic sclerosis.

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).


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