FDA grants FibroGen monoclonal antibody pamrevlumab for orphan drug treatment of Duchenne muscular dystrophy
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, FibroGen's(http://announced that theAdministration of the food anddrugs
(http://Administration (
FDA(http://) has granted the experimental anti-CTGF monoclonal antibody rectoratostol to treat Duchenne muscular dystrophy (DMD)About pamrevlumabpamrevlumab is a pioneering (first-in-class) whole-human antibody developed by FibroGen that targets the activity of connective tissue growth factors (CTGF)CTGF is the central medium of tissue remodeling and fibrosis, involving a wide range of fibrosis and hyperplasia, affecting the systemic organ systemThese diseases are characterized by persistent excessive scarring, leading to organ dysfunction and failure, many of which have few effective treatment options, including iacolycinais (IPF), pancreatic cancer, and duchonne muscular dystrophy (DMD)Previously, the FDA had granted pamrevlumab the right to treat IPF, pancreatic cancer, orphan drugs, and fast-track eligibilityClinical development, pamrevlumab treatment of IPF and pancreatic cancer is preparing to enter Phase III clinical treatment DMD in Phase II clinical In all studies, pamrevlumab showed consistent good safety and tolerance Now, roxadustat is being developed by FibroGen in conjunction with Astellas and AstraZeneca On December 18 last year, Rosasta capsules (product name: Eryjo, INN generic name: roxadustat, fG-4592) were approved by the National Medicines (http:// Supervision Authority (NMPA) for the treatment of patients receiving dialysis for anemia caused by chronic kidney disease (CKD) it's worth noting that China was the first country to approve Roxadustat In the Chinese market, AstraZeneca will be responsible for the commercialization of roxadustat
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