US and EU filings for Ofev in rare autoimmune condition

18 March 2019

Privately-held German firm Boehringer Ingelheim has filed to broaden the label for Ofev (nintedanib), to include patients with systemic sclerosis associated interstitial lung disease (SSc-ILD), also known as scleroderma.

It is estimated that up to 2.5 million people worldwide have scleroderma, a rare and potentially life-threatening condition characterized by thickening and scarring of connective tissue throughout the body.

Boehringer has applied for marketing approval in both the USA and in Europe, and will share clinical trial results used in the application during the American Thoracic Society Congress in May.

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