FDA grants Fast Track designation to nintedanib
FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
FESCA is very happy to share the news, that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to 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, randomized, placebo-controlled global Phase III trial. This pivotal study is fully enrolled, including more than 520 patients from 32 countries.
The President of FESCA, Annelise Rønnow, says: “There are only a very few drugs assessed in clinical trials for scleroderma with lung involvement – a devastating reality for people living with the disease. We appreciate that the FDA recognised the importance of the development in this field”.
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