FDA Issues Guidance for Development of Directing-acting Antiviral Drugs for Hepatitis C

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http://www.hivandhepatitis.com/hep_c/news/2010/0917_2010_a.html

FDA Issues Guidance for Development of Directing-acting Antiviral Drugs for

Hepatitis C

SUMMARY: The U.S. Food and Drug Administration (FDA) this week issued draft

guidelines to assist pharmaceutical companies in developing and gaining approval

for direct-acting agents targeting hepatitis C virus (HCV). Numerous such drugs

are now in the pipeline, with the HCV protease inhibitors telaprevir and

boceprevir nearest the finish line. The guidance outlines the types of

non-clinical studies and clinical trials that should be done, specifying that

some trials should include people with compensated and decompensated liver

cirrhosis and HIV/HCV coinfected patients. The FDA welcomes comments on the

draft through November 15.

Below is the text of an FDA e-mail message describing the draft guidance and the

comment procedure.

FDA Hepatitis Update -- Availability of draft Guidance:

Chronic Hepatitis C Virus Infection:

Developing Direct-Acting Antiviral Agents for Treatment

September 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availability of draft guidance for industry entitled " Chronic Hepatitis C Virus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/GuidanceComplianceRegulatoryInformation/Guida\

nces/UCM225333.pdf.

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?

R=0900006480b4e9b3.

FOR FURTHER INFORMATION CONTACT:

Murray,

Center for Drug Evaluation and Research,

Food and Drug Administration,

10903 New Hampshire Ave.,

Bldg. 22, rm. 6360,

Silver Spring, MD 20993-0002,

301-796-1500.

The complete Federal Register Notice announcing availability of this draft

guidance is available at http://edocket.access.gpo.gov/2010/pdf/2010-22806.pdf.

9/17/10

Source

R 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.