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March 19, 2019

Boehringer Ingelheim files for regulatory approval of nintedanib

Boehringer Ingelheim has filed regulatory submissions with the Food and Drug Administration and European Medicines Agency for approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease.

Boehringer Ingelheim has filed regulatory submissions with the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).

The company’s regulatory submissions are aimed at improving the lives of people living with pulmonary fibrosis. It specialises in developing drugs and treatments for those affected by rare diseases with a high level of umet need.

Nintedanib has already secured approval as an anti-fibrotic medicine in more than 70 countries to treat patients with idiopathic pulmonary fibrosis (IPF), a chronic and ultimately fatal disease characterised by a decline in lung function.

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

“SSc-ILD has a devastating impact on those it affects, often women in the prime of their lives.”

The disease can lead to scarring of the skin, heart and kidneys alongside ILD, which can be debilitating and may eventually lead to loss of life.Systemic sclerosis impacts four times as many women as men and is a relatively early-onset chronic condition, typically manifesting between the ages of 25-55.

Around a quarter of scleroderma patients develop pulmonary disease within three years of diagnosis, which is the leading cause of death among people with the condition.

Boehringer Ingelheim Respiratory Medicine associate head Dr Susanne Stowasser 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.”

Boehringer’s Vargatef (nintedanib) in combination with docetaxel was recommended by the UK’s National Institute for Health and Care Excellence (NICE) in June 2015 to treat patients with non-small cell lung cancer (NSCLC).

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