The first interstitial pulmonary disease (ILD) drug! Bollinger Ingham Ofev (Nidanib) 3rd Indicationist is about to be approved in the EU!
Last Update: 2020-06-17
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, 09 June 2020 /PRNewswire/ -- Boehringer Ingelheim,
european Medicines Agency (EMA), has issued an active review by the Human Pharmaceutical Products Commission (CHMP) Opinion, recommended approval of Ofev (nintedanib, Nidanib) a new indication, for the treatment of patients with developed phenotypes, in addition to isoplastic pulmonary fibrosis (IPF) and other chronic fibrosis interstitial pulmonary disease (ILD)ChMP's comments will now be referred to the European Commission, which usually makes a final review decision within two monthsOfev is a multi-target tyrosine kinase inhibitor that inhibits the key pathways involved in pulmonary fibrosis in interstitial pulmonary disease (ILD)Previously, Ofev has been approved for two indications: (1) for the treatment of iexclusiveized pulmonary fibrosis (IPF) ;(2) for the treatment of systemic sclerosis-related interstitial pulmonary disease (SSc-ILD)note that Ofev recently approved the drug in the United States and Canada as the first drug to treat patients with chronic fibrosis with an aggressive phenotype, marking a major milestone in the treatment of the diseaseOfev is now available in patients with chronic fibrosis ILD patients with persistent deterioration of pulmonary fibrosis"Pulmonary fibrosis is a major challenge for people with ILD, causing irreversible damage to the lungs, worsening respiratory symptoms and reducing quality of life," said Peter Fang, senior vice president and head of inflammation in the treatment area atBollinger InghamWe are very pleased with CHMP's comments and look forward to bringing the first treatment to the patient population who are not currently approved"
interstitial pulmonary disease (ILD) includes more than 200 groups of diseases that can cause pulmonary fibrosis, an irreversible scar of lung tissue that has a negative impact on lung functionPatients with ILD can develop into a sexual phenotype that causes pulmonary fibrosis, resulting in decreased lung function, decreased quality of life, and early death similar to the most common iexclusiveform interstitial pneumonia, iexclusivepaltic fibrosis (IPF)The course and symptoms are similar in the ongoing fibrosis ILD regardless of the underlying diseaseIt is estimated that up to 18-32% of non-IPF ILD patients are at risk of developing a phenotype of developed fibrosisCHMP's positive review, based on the results of Phase III INBUILD studies, this is the first clinical study to reach the primary endpoint in the ILD patient population INBUILD is the first
clinical trial to group patients in the field of ILD based on clinical behavior rather than major clinical diagnosis The study, a randomized, double-blind, placebo-controlled, parallel group study, was conducted in 153 clinical centres in 15 countries and evaluated the efficacy, safety and tolerance of Ofev (150mg, 2 times a day) for 52 weeks of treatment in patients with sexual fibrosis ILD The main endpoint was the annual decline in force lung capacity (FVC) assessed during the 52-week period of treatment data showed that fVC fell by 188 milliliters in the one-year treatment of patients in the placebo group and 81 milliliters in the Ofev treatment group This meant that Ofev slowed the decline in lung function by 57% compared to placebo In this study, Ofev's treatment for reducing lung function was consistent in all patients, regardless of the fibrosis pattern on high-resolution computed tomography (HRCT) and consistent with Ofev's trial results for patients with IPF and SSc-ILD study, Ofev was associated with a lower numerical reduction in the risk of acute exacerbation or death compared to placebos Treatment benefits are also accompanied by a decrease in patient reported results such as worsening of breathing difficulties and coughing The safety observed in the study was consistent with the of IPF and SSc-ILD clinical trials, with the most common adverse event being diarrhea, with 66.9% and 23.9% of the incidence of the Ofev treatment group and the placebo group, respectively (BioValleyBioon.com) original source: Boehringer Ingelheimer receives s positive CHMP opinion for a third nintedanib ar gyfer fibrois
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