Ofev set for new US approval, in scleroderma

26 July 2019

Privately-held German firm Boehringer Ingelheim has been given a positive decision from the US regulator’s advisory committee regarding Ofev (nintedanib).

While the US Food and Drug Administration is not bound by the recommendation, it usually follows the advice of the committee, which voted 10 to 7 in favor of approval for the treatment of systemic sclerosis associated interstitial lung disease, or SSc-ILD, also known as scleroderma.

The recommendation comes just a few months after Boehrginer applied to broaden the label to include the rare autoimmune condition, which is severe and often fatal. The firm has also submitted an application in Europe.

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