Regulatory Focus™ > News Articles > New Draft Guidance Intended to Clarify Data Requirements for Submission of HCV Data

New Draft Guidance Intended to Clarify Data Requirements for Submission of HCV Data

Posted 25 February 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new attachment to its existing draft guidance to industry regarding the specific submission of Hepatitis C virus (HCV) resistance data.

Background

FDA's 2009 final guidance, Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies, was intended to assist in the development of new antiviral drugs and biologics by establishing which data are essential to the review of an investigation new drug (IND), new drug application (NDA) or biologics licensing application (BLA).

Five specific topics were broached by the guidance: How to define a product's mechanism of action, how to establish the product's antiviral activity, how to assess the product's interaction with other products, which data are necessary to show evidence of viral resistance, and which data identify cross-resistance to approved antiviral products with the same target mechanism.

The guidance is unusual in that FDA has generated four disease-specific guidance attachments for four separate diseases: Human immunodeficiency virus (HIV), influenza, Hepatitis B and Hepatitis C.

New Guidance Heavy on Data Specifics

In 2006, FDA released a guidance attachment for HCV data. The three-page attachment provided a basic outline of the data suggested by FDA, including which data to include with specific sections.

But now, seven years later, FDA is out with an updated version of that same attachment which scraps its general suggestions in favor of a highly detailed, line-by-line data submission approach. The 16-page draft guidance notes that while it is "not intended to be applicable to all situations," it should be used for the submission of data from phase 3 and larger phase 2b efficacy trials.

Unlike the earlier draft guidance, the 2013 one is far more concerned about formatting, listing dozens of specific data input variables.

FDA said adherence to the formatting would be extremely important. "To identify any potential formatting problems as early as possible, all sponsors are encouraged to submit preliminary (or mock) resistance datasets to the Division of Antiviral Products (DVAP) before assembling formal clinical trial resistance datasets," FDA explains in the guidance.

These data entries are divided into four categories: patient data, endpoints data, genotypic data, and phenotypic data.

Comments on the draft guidance attachment are due by 26 April 2013.


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