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Friday, September 6, 2019

FDA OKs Boehringer Ingelheim’s Ofev for rare lung disease

The FDA approves privately held Boehringer Ingelheim’s Ofev (nintedanib) to slow the rate of decline in pulmonary function in adult patients with interstitial lung disease associated with systemic sclerosis, a rare disorder of unknown cause characterized by diffuse scarring and vascular abnormalities in the internal organs, skin and joints, or scleroderma, a chronic connective tissue disorder characterized by the hardening and tightening of the skin and connective tissues.
The agency first approved the kinase inhibitor in October 2014 for ideopathic (unknown cause) pulmonary fibrosis (IPF).
Systemic sclerosis/scleroderma-related tickers: Kadmon (KDMN +1.6%), Corbus Pharmaceuticals (CRBP +4.8%), Galapagos NV (GLPG -0.6%), Roche (OTCQX:RHHBY +1%), Emerald Health Pharmaceuticals (OTCQX:EMHTF +2.6%), Fibrocell Science (FCSC -1.1%)
IPF-related tickers: MediciNova (MNOV -1.1%), Trevi Therapeutics (TRVI +12.9%)

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