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Pegasys ® Hoffmann-La Roche BLA 103964-0 CMC Presentation Dr. Emanuel F. Petricoin, OTRR/CBER

Pegasys ® Hoffmann-La Roche BLA 103964-0 CMC Presentation Dr. Emanuel F. Petricoin, OTRR/CBER. Antiviral Drugs Advisory Committee Bethesda, Maryland November 14, 2002. Center for Biologics Evaluation and Research. ACTIVE BIOLOGIC AGENT DESCRIPTION:. Interferon alfa-2a:

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Pegasys ® Hoffmann-La Roche BLA 103964-0 CMC Presentation Dr. Emanuel F. Petricoin, OTRR/CBER

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  1. Pegasys® Hoffmann-La RocheBLA 103964-0CMC PresentationDr. Emanuel F. Petricoin, OTRR/CBER Antiviral Drugs Advisory Committee Bethesda, Maryland November 14, 2002 Center for Biologics Evaluation and Research

  2. ACTIVE BIOLOGIC AGENT DESCRIPTION: Interferon alfa-2a: Recombinant human leukocyte IFN produced in E. coli. MW: Approximately 19 kDa Peg-interferon: MW pegylated: approx. 63 kDa Lysine-based pegylation site the pegylated molecule is composed of isoforms Center for Biologics Evaluation and Research

  3. Roche Penzberg • PAI inspection: July 2002 • Shearwater Corp: PEG Reagent • Roche Nutley • PAI inspection: August 2002 Center for Biologics Evaluation and Research

  4. MANUFACTURING CHANGES and CLINICAL COMPARABILITY TESTING • Changes in manufacturing from Phase III material to commercial product • Multiple changes made to product and manufacturing to address market supply. • Changes required evaluation of analytical comparability and pharmacokinetic profile. PK comparability not demonstrated. • Product specifications were tightened. • A PK trial was performed comparing the phase III material to the commercial product • This trial demonstrated comparability of the phase III material to the commercial product Center for Biologics Evaluation and Research

  5. BLA TIMELINE Peginterferon alfa-2a BLA • Received: May 22, 2000 • Complete Response letter issued April 10, 2001- PDUFA goal date: April 12, 2001 • Meeting and consultations between CBER and the sponsor- Clinical trial to evaluate PK comparability initiated and completed: April, 2001- April, 2002 • Response to Complete Response letter received: April 16, 2002 • PDUFA Action Goal Date: October 16, 2002 • Application Approved: October 16, 2002 Peginterferon alfa-2a and Ribavirin BLA/NDA • Received: June 3, 2002 • PDUFA Action Goal Date: December 3, 2002 Center for Biologics Evaluation and Research

  6. CONCLUSIONS • Changes in manufacturing made after phase III trials to address market supply required demonstration of PK comparability to the commercial product • The Agency worked with Hoffmann-La Roche as they thoroughly evaluated the PK and analytical data • Product specifications tightened to ensure product consistency, robustness of the process and PK equivalency • All CMC issues and pre-approval inspection items are resolved Center for Biologics Evaluation and Research

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