FDA grants Brynering Ingeheim's breakthrough drug
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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The u.Sfood anddrug(http://Administration (
FDA(http://has granted its oral small molecule tyrosine kinase inhibitor, Oftedanib, Nidanibu, a breakthrough drug qualification (BTD), the germanPharmaceutical(http://giant Bollinger Ingham announcedOfev (nintedanib) is currently under FDA review for the treatment of patients with progressive ghemotopulmony (ILD)This breakthrough drug qualification is based on the results of the Phase III INBUILD study, the first clinical study to reach a major endpoint in the ILD patient populationINBUILD is the first clinical
trial trial (http:// in the field of ILD to group patients based on clinical behavior of the disease rather than the primary clinical diagnosis The study, a randomized, double-blind, placebo-controlled, parallel group study conducted in 153 clinical centers in 15 countries, assessed the efficacy, safety and tolerance of Ofev (150 mg, 2 times a day) for treatment of patients with sexual fibrosis ILD for 52 weeks The results showed that Ofev slowed lung function decline by 57% across the study group, based on an assessment of the annual rate of reduction in the amount of strong exhalation (FVC) in patients with sexual phenotype fibrosis ILD over a 52-week week In terms of safety
the most common adverse events in the study were diarrhea, with the incidence of 66.9% in the Ofev treatment group and 23.9% in the placebo group, respectively, and ofev safety was consistent with previous studies
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