Systemic sclerosis-related interstitial pulmonary disease, the first treatment drug approved in China!

The approval of nidanib marks that patients with SSc ILD are out of the dilemma of no medicine to treat, which is of milestone significance for the treatment of the disease.on June 8, 2020, bringer Ingelheim announced the anti pulmonary fibrosis treatment drug vegat (English Name: ofev, The generic name: nidanib ethylsulfonate soft capsule) has been approved by the State Drug Administration of China (nmpa), becoming the first and the only drug used for systemic sclerosis related interstitial lung disease (SSC ILD), which marks that patients with SSc ILD have gone out of the dilemma of no medicine, which has a milestone significance for the treatment of the disease The second indication approved in China.it is worth mentioning that the indication was submitted by Boehringer Ingelheim in China for the first time (June 2019), and the approval of China was only one and a half months after the EU's approval.at present, nidanib has been approved for the treatment of idiopathic pulmonary fibrosis (IPF) in more than 70 countries (including China), and has been approved for the treatment of SSC ILD in 15 countries. It has been proved that it can delay the progression of disease by slowing down the annual decline rate of pulmonary function (forced vital capacity).systemic sclerosis (SSC), also known as scleroderma, is a rare autoimmune disease that affects multiple organs of the body and can not be cured. It can cause scar formation (fibrosis) of skin and viscera (such as heart, lung, digestive tract and kidney) [1-3].SSC occurs in the lung and can cause interstitial lung disease, known as SSC ILD [1-2]. About 25% of SSc patients have significant lung involvement within 3 years after diagnosis [5].SSC ILD is a progressive lung disease. Many patients have no symptoms in the early stage, but the prognosis is poor and the survival rate is low.it is a key driver of death in SSc patients [3-4].Professor Zeng Xiaofeng, director of Rheumatology and Immunology Department of Peking Union Medical College Hospital, President of Rheumatology and Immunology branch of Chinese Medical Association, former chairman of Rheumatology branch of Chinese Medical Association, director of Rheumatology and Immunology Department of Peking Union Medical College Hospital, President of Rheumatology and Immunology doctor branch of Chinese Medical Association, and former chairman of Rheumatology branch of Chinese Medical Association, said: "at present, clinical practice The biggest problem is that even if SSC ILD patients are definitely diagnosed, there is no drug approved for marketing.the new indication of nidanib is approved, which represents a significant scientific progress in the treatment of SSC ILD, a rare disease. It will bring hope to patients suffering from this serious disease and their families."new indications for nidanib were approved. The SSC ILD based phase III senscis clinical study was conducted.it is the largest randomized controlled trial for SSC ILD patients, covering 32 countries and regions, involving 576 patients. Nine research centers in China participated in the trial.studies have confirmed that compared with placebo, nidanib can slow down the decline of lung function in patients with SSc ILD.the annual decline rate of lung function in SSc ILD patients treated with nidanib was reduced by 44% (based on FVC assessed during 52 weeks) [1].this study demonstrates that nedanib can delay disease progression by slowing down the annual decline rate of pulmonary function (forced vital capacity).the results of the study were published in the New England Journal of medicine.Pavol dobroky, general manager of human drugs in Greater China of bringer Ingelheim, said: "the efficacy and safety of nidanib have been fully supported by clinical research data. We believe that the approval of this new indication in China will benefit SSC ILD patients in China and send them the hope of being medicated. this is the second indication approved by nidanib in China, and its third indication for the treatment of chronic fibrotic interstitial lung disease (pf-ild) with progressive phenotype has been approved in the United States and Japan recently. In December last year, China also submitted an application for listing globally. we are looking forward to working closely with relevant departments to jointly promote more breakthroughs in the treatment of interstitial lung disease, so that Chinese patients can use new and good drugs faster and earlier, and help "healthy China 2030". SSc patients, founder of Zheng AI's scleroderma care home, said: "SSC brings us great damage. It will not only change our appearance, but also cause visceral fibrosis. When the disease affects the lungs, it will make it difficult for us to breathe, which greatly affects our daily life. although SSC can not be cured at present, it can coexist with it through drug treatment. We are very happy that the indication of nidanib in the treatment of SSC ILD has been approved. "as a small molecule tyrosine kinase inhibitor, nidanib can simultaneously block three kinds of growth factor receptors, including vascular endothelial growth factor receptor, platelet-derived growth factor receptor and fibroblast growth factor receptor, and effectively inhibit the signal pathway in the process of fibrosis. important milestone in October 2014, it was approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF). in 2015, it was included in the international guidelines, and was included in the Chinese IPF diagnosis and treatment expert consensus in 2016. in September 2017, it was approved by China nmpa to be listed in China for the treatment of IPF. in January 2018, it entered the list of serious diseases Medical Insurance in Zhejiang Province, and launched the IPF patient assistance program in the same year. in March 2019, Boehringer Ingelheim announced that it had submitted the application for the listing of nidanib for SSC ILD to FDA and EMA. in June 2019, Boehringer Ingelheim China submitted the listing application of SSC ILD indications to China nmpa. in September 2019, the US FDA approved nidanib as the first and only drug that can slow down the decline of lung function in patients with SSc ILD. in October 2019, the FDA of the United States authorized the use of nifedib as a breakthrough therapy for chronic fibrotic interstitial lung disease with progressive phenotype. at the same time, this indication has also been submitted to other regulatory bodies including EMA. in December 2019, China nmpa officially accepted the application for registration of indications for the treatment of progressive fibrosis interstitial lung disease (pf-ild). in March 2020, the United States FDA approved nidanib as the first drug for the treatment of chronic fibrotic interstitial lung disease with progressive phenotype. in April 2020, EMA approved the use of nidanib in the treatment of SSC ILD. in June 2020, China's nmpa approved the indications for nidanib SSC ILD. References: [1] discler o, et al. Nintedanib for systemic sclerosis associated interactive lung disease. N English J Med. Published, 20 May, 2019 NEJM.org . DOI: 10.1056/NEJMoa1903076[2] Distler O, et al. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Eng J Med. Published 20 May, two thousand and nineteen NEJM.org . DOI: 10.1056/NEJMoa1903076[3] Cottin V, et al. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respir. Res. 2019;20(1):13[4] Denton CP, Khanna D. Systemic sclerosis. Published 13 April, 2017 Last accessed March 2019.[5] Solomon JJ, Et al. European Respiratory update: scleroderma lung disease. EUR. Respir. Rev. 2013; 22:127, 6 – 19. - end love me, please!