Genfit's PPAR alpha/double agonist elafibranor is eligible for orphan medicine by FDA and EMA
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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PBC is a rare liver disease, mainly due to the bile duct (functioning to transport bile out of the liver) by autoimmune damage, resulting in bile siltation, inhibits the liver's ability to remove toxins from the body, and leads to liver tissue scarring, i.ecirrhosisThe(http:// of Genfitannouncedthat the u.SFood andMedicines(http://Administration (
FDA(http://) and the EuropeanDrug(http://Authority (HTTP://WWW.CHEMDRUG.COM/) have granted its lead drug, PPAR alpha/double agitator, the treatment of primary bile bile ductitis (PBC) orphan drug
In April 2019, the FDA also granted elafibranor breakthrough drug eligibility (BTD) for the treatment of adult Patients with under-responsive Psychedelic acid (UDCA) in bears About elafibranor
elafibranor is a first-of-the-first(first-in-class) peroxidase-activating receptor alpha and pyridox (PPAR alpha/synostic) double agonist, and positive safety and efficacy results have been obtained in pBC adult patients who treated UDCA in phase II Currently, elafibranor is also evaluating the potential for treatment of non-alcoholic fatty hepatitis (NASH) in Phase III clinical studies The study the BTD grant, based on data from a randomized, double-blind, placebo-controlled Phase II clinical study, in adult patients with inadequate Response to UDCA The results showed that elafibranor significantly reduced the level of alkaline phosphatase (ALP), showed significant therapeutic effect in the primary endpoint compared to placebo, and also reached the compound endpoint for drug registration In addition to a significant reduction in ALP, other PBC markers in the two groups, including gamma-glutamine transferase (GGT), lipid markers (total cholesterol, LDL and triglycerides), and anti-inflammatory markers (IgM, CRP, binding belitosin, and fibrinogen), also showed improvements In terms of safety
studies, 2 doses of elafibranor were well tolerated Genfit plans to launch Phase III clinical studies in 2019 to further evaluate the efficacy and safety of elafibranor's treatment of PBC
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