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FDA Panel Narrowly Backs Ofev Label Expansion |
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FDA Panel Narrowly Backs Ofev Label Expansion
eMediNexus,  27 July 2019
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#Internal Medicine #Pharmacist #Pulmonary Medicine

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An FDA advisory committee voted 10-7 that nintedanib (Ofev) should be approved to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Currently marketed to treat idiopathic pulmonary fibrosis (IPF), nintedanib would become the first drug approved for SSc-ILD, a condition with few other options for treatment.

The main data supporting the label expansion came from the phase III, double-blind, placebo-controlled SENSCIS trial involving some 580 patients across 32 countries… (Medpage Today)

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