Below is the text of an FDA e-mail message describing the draft
guidance and the comment procedure.
Hepatitis Update -- Availability of draft Guidance:
Chronic Hepatitis C Virus Infection:
Developing Direct-Acting Antiviral Agents for Treatment
14, 2010 -- The Food and Drug Administration (FDA) is announcing
the availability of draft guidance for industry entitled "Chronic
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral
Agents for Treatment." At present, there are a large number
of drugs for the treatment of chronic hepatitis C (CHC) in active
development. The purpose of this guidance is to assist sponsors
in all phases of development of direct-acting antiviral agents
(DAAs), defined as agents that interfere with specific steps
in the hepatitis C virus (HCV) replication cycle. The guidance
outlines the types of non-clinical studies and clinical trials
recommended throughout the drug development process, such as
early phases of clinical development, phase 3 protocol designs,
and endpoints for the treatment of CHC to support approval of
treatments for CHC, including patients with compensated and
decompensated cirrhosis and those co-infected with HIV. The
guidance also addresses pre-approval access in the form of treatment
investigational new drug applications (INDs) and intermediate-sized
safety protocols (collectively known as expanded access).
Important issues addressed in this guidance include: drug development
methods to reduce the emergence of drug resistance, types of
trial designs to assess optimal dose and treatment duration,
combination therapy with multiple investigational drugs, recommendations
on development of drugs to meet unmet medical needs, and use
of treatment INDs or other smaller safety protocols to provide
early access of multiple DAAs for patients at risk of imminent
progression of liver disease.
The draft guidance, when finalized, will represent the agency's
current thinking on developing DAAs for treatment of CHC virus
infection. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
The draft guidance is available on the FDA web site at http://www.fda.gov/downloads/Drugs/
Although comments are accepted for any guidance at any time,
to ensure that the agency considers your comment on this draft
guidance before it begins work on the final version of the guidance,
please submit written or electronic comments on the draft guidance
by November 15, 2010, and include the docket number, FDA-2010-D-0462,
in any comment you submit.
You may submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852
You may also submit electronic comments at http://www.regulations.gov/search/Regs/home.html#submitComment?
FOR FURTHER INFORMATION CONTACT:
Center for Drug Evaluation and Research,
Food and Drug Administration,
10903 New Hampshire Ave.,
Bldg. 22, rm. 6360,
Silver Spring, MD 20993-0002,
The complete Federal Register Notice announcing availability
of this draft guidance is available at http://edocket.access.gpo.gov/2010/pdf/2010-22806.pdf.
Klein and K Struble. FDA Hepatitis Update -- Availability of
draft Guidance: Chronic Hepatitis C Virus Infection: Developing
Direct-Acting Antiviral Agents for Treatment. U.S. Food and
Drug Administration. September 14, 2010.