September 16, 2013

FDA Antiviral Drugs Advisory Committee set for October 24 to consider HCV New Drug Application (NDA) 205123, Simeprevir

Food and Drug Administration

Food and Drug Administration 
[Docket No. FDA-2013-N-0001]
Antiviral Drugs Advisory Committee; Notice of Meeting
AGENCY:  Food and Drug Administration, HHS.
ACTION:  Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be open to the public.

Name of Committee: Antiviral Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on October 24, 2013, from 8 a.m. to 5 p.m.

Location: Sheraton Silver Spring Hotel, Cypress Ballroom, 8777 Georgia Ave., Silver Spring, MD.  The hotel phone number is 301-589-0800.

Contact Person: Karen Abraham-Burrell, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email:, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide
timely notice.  Therefore, you should always check the Agency's Web site at and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Agenda:  The committee will discuss 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. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function. 

FDA intends to make background material available to the public no later than 2 business
days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.  Background material is available at Scroll down to the appropriate
advisory committee meeting link.

Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before October 9, 2013.  Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 1, 2013.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by October 2, 2013.

Persons attending FDA's advisory committee meetings are advised that the Agency is not
responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will
make every effort to accommodate persons with physical disabilities or special needs. If you
require special accommodations due to a disability, please contact Karen Abraham-Burrell at
least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at for
procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.

Dated:  September 11, 2013. 
Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs.   
[FR Doc. 2013-22546 Filed 09/16/2013 at 8:45 am; Publication Date: 09/17/2013]

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