New Drug Application Filing: Intercept Pharmaceuticals and UI Pharmaceuticals
University of Iowa Pharmaceuticals (UIP) is pleased to report that its long standing client, Intercept Pharmaceuticals, Inc. announced that it has filed a New Drug Application for accelerated approval with the U.S. Food and Drug Administration (FDA) and acceptance of the Marketing Authorization Application (MAA) by the European Medicines Agency (EMA).
The application is for a product called obeticholic acid (OCA), which is intended for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Intercept Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases. They contracted with UIP to develop a preliminary formulation and analytical testing methods for this product when it entered the drug development process. As the product moved through the development process, manufacturing operations were moved to another facility due to scale limitations at UIP. Analytical testing has continued to be performed by UIP, and UIP is named as a qualified laboratory for testing of commercial product intended for United States market.
This is the fifth commercial prescription product for which a UIP client has filed for regulatory approval with UIP named as a production and/or analytical testing site in the past 6 years.
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