FDA
18th December 2013

AdComm Roll Call Special – Spotlight on: AVDAC

The Antiviral Drugs Advisory Committee (AVDAC) has the responsibility of reviewing and evaluating available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections, and makes appropriate recommendations to the Commissioner of Food and Drugs. 

AdComm Roll Call Special – Spotlight on: AVDAC

The Antiviral Drugs Advisory Committee (AVDAC) has the responsibility of reviewing and evaluating available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections, and makes appropriate recommendations to the Commissioner of Food and Drugs. 

So far this year, AVDAC has met twice, both times in October. The first meeting (October 24th) consisted of a discussion regarding the new drug application (NDA) 205123, simeprevir (a hepatitis C virus protease inhibitor), manufactured by Janssen Pharmaceutical Co., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C) in adult patients with compensated liver disease (including cirrhosis) who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. The second meeting on the following day consisted of a discussion regarding the new drug application 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc., with the proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. 

Both meetings ended in favor of drug approval. Simeprevir was unanimously recommended by the panel for the treatment of chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, combined with peginterferon alfa and ribavirin in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy with or without ribavirin. View the entire meeting outcome blog here!

AVDAC also unanimously recommended approval of sofosbuvir in combination with ribavirin for the treatment of adults with chronic hepatitis C virus genotypes (GT) 2 and 3 infections. Furthermore, the committee also fully supported sofosbuvir in combination with pegylated interferon and ribavirin for treatment of chronic HCV in treatment-naïve adults with GT 1 and 4 infections who have not received prior therapy. View the entire meeting outcome blog here!

AVDAC consists of a core of 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of clinical pharmacology, internal medicine, infectious diseases, microbiology, virology, psychiatry, statistics, epidemiology, ophthalmology, immunology, pediatrics, hematology, and related specialties. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Please click HERE for a list of individuals currently on the AVDAC roster.

Preparing for an AVDAC meeting? Learn more about ISS’ Strategic Approach to Advisory Committee Prep!

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