[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Page 15868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 15868]]



Food and Drug Administration

[Docket No. 2005D-0106]

Draft Guidance for Industry on Systemic Lupus Erythematosus--
Developing Drugs for Treatment; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Systemic Lupus 
Erythematosus--Developing Drugs for Treatment.'' The draft guidance is 
intended to provide recommendations for industry on developing drugs 
for the treatment of systemic lupus erythematosus (SLE). Specific 
topics include measurement of lupus disease activity and clinical 
outcomes, reduction in disease activity and flares, treatment of organ-
specific disease, trial design issues and analysis, surrogate markers 
as endpoints, and risk-benefit assessment.

DATES:  Submit written or electronic comments on the draft guidance by 
June 27, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Submit written comments on the draft 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 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. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Send one self-addressed adhesive label to assist the office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

    Joel Schiffenbauer, Center for Drug Evaluation and Research (HFD-
550), Food and Drug Administration, 9201 Corporate Blvd., suite N316, 
Rockville, MD 20850, 301-827-2090; or
    Jeffrey N. Siegel, Center for Drug Evaluation and Research (HFD-
108), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5667.


I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Systemic Lupus Erythematosus--Developing Drugs for 
Treatment.'' SLE is a chronic disease characterized by protean 
manifestations often demonstrating a waxing and waning course. In the 
past, a diagnosis of SLE often implied a decreased life span due to 
internal organ system involvement or to toxic effects of therapy. 
However, recent improvements in care have dramatically enhanced the 
survival of SLE patients with the most severe and life-threatening 
manifestations. Unfortunately, current treatments for SLE remain 
inadequate as many patients have incompletely controlled the disease, 
progression to end-stage organ involvement continues, and current 
therapies carry potential risks of debilitating side effects. 
Therefore, it is important to clearly describe acceptable endpoints for 
approval to facilitate the development of novel therapeutic agents 
which have the potential to be more effective and/or less toxic.
    This draft guidance provides a general discussion of outcomes and 
measurements of lupus disease activity including the use of disease 
activity indices, flares, and organ-specific outcomes. It presents the 
indications that the agency may be willing to approve at present for 
new drug therapies for lupus. It also presents general trial design 
issues, discusses the use of surrogate endpoints in relation to lupus, 
presents the overall risk-benefit assessment that should be addressed 
for any new therapy of lupus, and presents some issues related to lupus 
and pharmacokinetics.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
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. Comments

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

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
    Dated: March 22, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6085 Filed 3-28-05; 8:45 am]