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    Home > Active Ingredient News > Drugs Articles > The first domestic pulmonary hypertension PDE5 inhibitor approved by the State Food and Drug Administration

    The first domestic pulmonary hypertension PDE5 inhibitor approved by the State Food and Drug Administration

    • Last Update: 2020-02-17
    • Source: Internet
    • Author: User
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    Pfizer puqiang recently announced that revatio (sildenafil citrate) has been approved by China National Drug Administration (nmpa) on February 5, 2020 to treat adult pulmonary hypertension (PAH, who group 1), so as to improve exercise ability and delay clinical deterioration This product is the first type 5 phosphodiesterase (PDE-5) inhibitor approved for the treatment of pulmonary hypertension in China Figure 1 Sildena citrate unstructured rivanto ® was developed by Pfizer Since 2005, it has been approved in the United States, Europe, Japan and other countries and regions for the treatment of pulmonary hypertension, saving a large number of patients' lives Rivanol ® is a high-quality imported drug for the treatment of pulmonary hypertension, containing 20 mg of sildenafil citrate (calculated according to sildenafil), which conforms to the single treatment dose recommended by PAH guidelines The delayed effect of clinical deterioration of this product has been proved in the clinical research based on the treatment of epoprost The main patients included in the study to prove the effectiveness were the patients with idiopathic PAH (71%) and those with connective tissue disease (25%) of who functional grade II-III In order to actively respond to the national attention to the rare disease of pulmonary hypertension (PAH) and the urgent clinical needs of patients, rivante ® was successfully approved in only 4.5 months after NDA was officially accepted by nmpa It's a good news for many years for the patients with pulmonary hypertension to be approved and listed in China, which will actively promote the popularization and standardization of the treatment of pulmonary hypertension in China Early diagnosis and correct treatment, and the "blue lips" breathing freely as a rare disease, the prevalence of pulmonary hypertension is about 15-60 per million people, with an incidence rate of 5-10/ million years According to this estimate, there are about 83700 people suffering from pulmonary hypertension in China, and about 7000-14000 new cases of pulmonary hypertension every year The distribution of PAH in China is different from that in western countries The most common disease in China is congenital heart disease, followed by idiopathic pulmonary hypertension (IPAH) and connective tissue disease-related PAH The most common causes of PAH associated with connective tissue disease are systemic lupus erythematosus and Sjogren's syndrome In China, the majority of IPAH are young and middle-aged women, but the elderly patients are relatively rare In the era of no targeted drugs, the 1 -, 3 -, and 5-year survival rates of primary pulmonary hypertension (IPAH) in the United States were 68%, 48%, and 34%, respectively Since the PAH targeted drugs were successively launched, the 1-year survival rate of patients with new IPAH, familial PAH, and amirex-related PAH was 89.3% registered in France in 2006 The results of follow-up study in France in 2010 showed that the new IPAH, genetic PAH, and amirel were newly developed The 1 -, 2 -, and 3-year survival rates were 89%, 68%, and 55%, respectively Before 2006, there was no PAH targeting drug in China The 1 -, 3 - and 5-year survival rates of IPAH and PAH were 68.0%, 38.9% and 20.8%, respectively After 2007, China gradually entered the era of targeted drugs In 2011, China's research showed that the 1-year and 3-year survival rates of IPAH were 92.1% and 75.1% respectively, basically reaching the level of western developed countries There is no specific clinical manifestation in the early stage of pulmonary hypertension, and the majority of patients have a significant delay in the treatment time More than half of IPAH patients were diagnosed with who cardiac function of grade Ⅲ to Ⅳ Some patients with pulmonary hypertension may only show basic disease-related symptoms in the early stage When pulmonary artery pressure is significantly increased, right heart failure may occur PAH targeted drug therapy is recommended for patients with unrepairable congenital heart disease-related PAH or postoperative PAH The main goals of treatment were to relieve symptoms and improve prognosis Some patients with PAH related to congenital heart disease who are in the critical indication of operation can even get the opportunity of operation after targeted drug therapy of PAH Table 1 List of PAH targeted drugs: the first tier of research and development of pde5a inhibitors by many Chinese Enterprises: tpn729ma is jointly developed by Henan Tianfang, Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, Shanghai specialty pharmaceutical technology and Shandong tepharman Pharmaceutical (subsidiary of Shanghai specialty pharmaceutical technology), which is intended to be used for the treatment of erectile dysfunction The second echelon: yonkenafil hydrochloride, developed by Jilin University, applied for clinical application by Tianshili (class 1.1) in China, and carried out clinical research by Yangzijiang pharmaceutical industry, which is currently in the second stage of clinical treatment of erectile dysfunction The third tier: fadanafil, ddci-01, xiongdenafil City, tpn171h Aildenafil citrate, developed by Beijing Wannianchun biomedical and Tianjin Pharmaceutical Research Institute, has applied for listing in China in 2009, but has not been approved for listing The drug may be authorized to yuekang pharmaceutical industry around 2013, and yuekang Pharmaceutical Group Co., Ltd started the clinical phase I trial of the drug in 2017 and 2018 Table 2 The list of 1 class of drugs targeting pde5a in China comes from the original title of drug delivery database: revanto ®: the first domestic PDE5 inhibitor of pulmonary hypertension approved by nmpa
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