The FDA's Antiviral Drugs Advisory Committee is well known for its review of investigational human drug products for use in the treatment of acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) related illnesses, and other viral, fungal, and mycobacterial infections. This Committee's recommendation led to the FDA's first-ever approval of an agent indicated for pre-exposure prophylaxis for HIV. The AVDAC, however, will make most of its headlines in the coming years with its deliberations on a host of Hepatitis C therapies that are currently preparing to file NDAs. More than two dozen of these inhibitory agents are now under development and span a variety of classes: Polymerase, Protease, NS5A, NS4B, NS3/4A, p7, and entry inhibitors.

ECG's experience with the Antiviral Committee dates back to the early days of the HIV epidemic. ECG supported two of the first three protease inhibitors ever approved for HIV as well as many of the therapies that have followed. ECG has led 15 client projects preparing for AVDAC meetings, virtually all of these projects for HIV or Hepatitis B or Hepatitis C indications. In 2011 the Committee only met twice for product approvals, with ECG supporting one of the two sponsors. In 2012, the AVDAC only considered two product approvals as well, and ECG supported both. It is expected that AVDAC will be meeting much more often in the coming years with the maturing of Hepatitis C drug development pipelines and the attendant applications they will generate.

Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming AADPAC meeting.