GL701 (DHEA, prasterone) for the Treatment of Systemic Lupus Erythematosus  (SLE) in Women

 

Briefing Document

FDA Arthritis Advisory Committee

 

 

April 19, 2001

 

Androgen effects on the endometrium references

AVAILABLE FOR PUBLIC DISCLOSURE

WITHOUT REDACTION

 

 

 

 

 

 

 

 

Genelabs Technologies, Inc.

505 Penobscot Drive

Redwood City, CA 94063

 

 

1     Table of Contents 2

2     Executive Summary 4

2.1       Background 4

2.2       Efficacy 4

2.3       Safety 6

2.4       Conclusions 8

3     Background 9

3.1       Rationale for DHEA as a Therapy in SLE 9

4     Development of GL701 for Systemic Lupus Erythematosus 12

4.1       Clinical Studies Supporting Efficacy and Safety of GL701 in SLE 12

4.2       Overview of Clinical Development Program for GL701 13

4.3       Pharmacology 13

4.3.1       Background 13

4.3.2       Pharmacokinetic Studies 15

4.3.3       DHEA-S Levels from GL701 Controlled Clinical Studies 23

5     Organization of Clinical Results 30

6     Well controlled Studies 33

6.1       Study GL94-01 (Corticosteroid Reduction Study) 34

6.1.1       Protocol Development 36

6.1.2       Entry Criteria 46

6.1.3       Study Activities 48

6.1.4       Patient Populations for Analysis 57

6.1.5       Efficacy Variables 59

6.1.6       Study Patient Population and Demography Results 62

6.1.7       Dosing Information 108

6.1.8       Efficacy Results 115