FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Drugs for Hepatology (Liver, Pancreatic, Gall Bladder) in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Seladelpar

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 23, 2020

            Details:

            CymaBay had halted all studies of seladelpar after liver biopsies showed some patients in a phase 2b NASH trial had inflamed and destroyed liver cells, a condition known as interface hepatitis.

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            Lead Product(s): Obeticholic Acid

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: OCA

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 21, 2020

            Details:

            Viewing the evidence from the study as a whole, ICMR feels that the long-term net effects of OCA on quality of life and health of patients with NASH and F2/F3 fibrosis are uncertain.

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            Lead Product(s): Obeticholic Acid

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 22, 2020

            Details:

            U.S.FDA has notified Intercept that its advisory committee meeting (AdCom) relating to the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed.

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            Lead Product(s): Resmetirom

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 14, 2020

            Details:

            Once daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at least 50% to more than 60% reductions in liver fat, respectively.