FDA grants Brynering Ingeheim's breakthrough therapy designation
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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today, the http://of the of the of the bouring fdae
company announced that the U.SFDA(http://granted its small molecule tyrosine kinase inhibitor, Ofev (nintedanib), as a breakthrough therapy for the treatment of patients with chronic sexualficosis interstitial pulmonary disease (ILD)About Ofev
Ofov is a small molecule tyrosine kinase inhibitor that simultaneously blocks three growth factor receptors, including vascular endothelial growth factor receptors, platelet-derived growth factor receptors, and fibroblast growth factor receptors, effectively inhibiting signaling pathways in fibrosisIn September 2019, Ofev was also approved in the United States to delay the decline in lung function in adult patients with systemic sclerosis-related interstitial pulmonary disease (SSc-ILD), the first approved treatment for this rare lung diseaseon INBUILD
this determination is based on a randomized, double-blind, placebo-controlled group of clinicallytrial(http://that assessed Ofev's safety, tolerance and efficacy in treating patients with sexually aggressive interstitial pulmonary diseaseTrial data showed that in week 52, The patient's treatment reduced lung function by 57% to the main endpoint of the trial through the patient's assessment of the Force Lung Capacity (FVC)Ofev slowed the progression of disease in patients with progressive fibrosis interscosisinal lung disease in the trial
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