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FDA Grants Boehringer Ingelheim Fast Track Status

For nintedanib, for the treatment of systemic sclerosis with associated interstitial lung disease

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Boehringer Ingelheim’s nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD).    This designation is based on Boehringer Ingelheim’s Investigational New Drug application (IND) of nintedanib for the treatment of SSc-ILD and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, ra...

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