E8-30086. Guidance for Industry on Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Mary Parks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3362, Silver Spring, MD 20993-0002, 301-796-2290.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” Diabetes mellitus is associated with an increased risk of cardiovascular disease. Reducing long-term cardiovascular complications in patients with diabetes should be an important goal of disease management. There are compelling data in patients with type 2 diabetes supporting a reduced risk of microvascular complications with improved long-term glycemic control. This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.

On March 3, 2008, FDA issued the draft guidance for industry entitled “Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention” (73 FR 11420). On July 1 and 2, 2008, the Endocrinologic and Metabolic Drugs Advisory Committee met to discuss the role of cardiovascular assessment in the premarketing and postmarketing settings for drugs and therapeutic biologics developed for the treatment of type 2 diabetes mellitus. After considering the discussion at this meeting as well as other available data and information, we have determined that concerns about cardiovascular risk should be more thoroughly addressed during drug development. We are issuing this guidance to ensure that our recommendations reach all sponsors who may submit applications for approval of drugs to treat type 2 diabetes mellitus.

We are issuing this level 1 guidance for immediate implementation, consistent with FDA's good guidance practices regulation (21 CFR 10.115). FDA is not seeking comment before implementing this guidance because of the need to immediately notify sponsors with ongoing development programs of the need to address cardiovascular risk in ongoing drug development programs. If FDA receives comments on this guidance, it will consider the comments and incorporate final recommendations into the final version of the March 2008 draft guidance.

This guidance represents the agency's current thinking on evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. 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.

II. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under 0910-0014, and the collections of information in 21 CFR part 314 have been approved under 0910-0001.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​cder/​guidance/​index.htm or http://www.regulations.gov.

Dated: December 1, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.