The first drug to develop interstitial pulmonary disease (PF-ILD) for fibrosis! Bollinger Ingham Ofev (Nidanib) EU approved for the third indication!

July 16, 2020 // Boehringer Ingelheim recently announced that the European Commission (EC) has approved of Ofev (Chinese: Vigat, generic name: nintedanib, Nidanib) for the treatment of other gliopathic chronic pulmonary disease (PFD) patients with the exception of isopulmonary fibrosis (IPF)Recently, Ofev's indications have also been approved by the United States, Canada and JapanIt is worth noting that Ofev is the first drug approved for the treatment of PF-ILD patients, 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 fibrosisOfev 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)In China, Ofev has been approved for treatment of IPF and SSc-ILD, and applications for treatment of PF-ILD were accepted by the State Drug Administration late last yearLiam Galvin, secretary of the European Union of Isoconalfibrofibros (EU-IPFF), said: "When living with a rare, life-threatening disease, it is very difficult and frightening to hear your voice, especially without treatment optionsThe European Commission's decision is great news for those at risk of pulmonary fibrosis due to sexual ILDPulmonary fibrosis leads to an irreversible decline in lung function, and this new indication sisyded will offer many hope to those affected patients and their loved onesPeter Fang, Senior Vice President and Head of Inflammation in the Treatment Area, Boehringer Ingham, said: "We are very pleased that the European Commission has approved Ofev as the first therapeutic drug for a group of therapeutic chronic fibrosis ILDPulmonary fibrosis can greatly affect the lives of PEOPLE with ILD, causing irreversible damage to the lungs, leading to worsening respiratory symptoms and decreased quality of lifeBut until now, there has been no approved treatment planThe approval offers new hope to these patients, a major breakthrough in treatment"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 disease It is estimated that up to 18-32% of non-IPF ILD patients are at risk of developing a phenotype of developed fibrosis The approval is based on the results of Phase III INBUILD studies, the first clinical study to reach the primary endpoint in the ILD patient population INBUILD is the first clinical trial in the field of ILD to group patients based on clinical behavior rather than major clinical diagnoses 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 The data showed that in one year, FVC was reduced by 188 millilitres in patients in the placebo group and 81 millilitres 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 In the study, Ofev was associated with a lower numerical value of acute exacerbation or death than 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 that of IPF and SSc-ILD clinical trials, with the most common adverse event being diarrhea, with 66.9% and 23.9% of the incidence sonofness in the Ofev treatment group and the placebo group, respectively () Original origin: European Commission approves s nintedanib oedd in pulmonary fibrosis.