Aslera.
Press Release Source: Genelabs Technologies, Inc.
Genelabs Receives Approvable Letter From FDA
Thursday August 29, 9:08 pm ET
REDWOOD CITY, Calif., Aug. 29 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB - News) announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter on August 28 for Genelabs' New Drug Application (NDA) for Prestara(TM) (prasterone), formerly known as Aslera(TM) or GL701. Prestara is being developed by Genelabs and is exclusively licensed to Watson Pharmaceuticals, Inc. (NYSE: WPI - News) in North America.
The FDA stated that they completed their review of the Prestara NDA and it is approvable. In Genelabs' Study GL95-02, a positive effect on bone mineral density was observed in women with mild to moderate systemic lupus erythematosus (SLE or lupus) while on low-dose glucocorticoids. Approval is contingent upon the successful completion of an additional clinical trial providing sufficient evidence to confirm this positive effect. In a teleconference today with the FDA, the agency indicated that bone mineral density should be the primary endpoint in this clinical trial which could have a six-month treatment duration. Following this initial discussion, Genelabs plans to have a formal meeting with the FDA as soon as possible to finalize details of the clinical trial design and discuss the remaining issues. Additional issues to be addressed in the approvable letter include, among other things, submission of data for the qualification of a manufacturing site.
"I am pleased that the FDA has concluded that the Prestara NDA is approvable and that they have provided guidance that gives us confidence that we can move forward expeditiously," stated Irene A. Chow, Ph.D., chairman and chief executive officer of Genelabs. "Bone mineral density measurements are objective and have been well validated as endpoints in other clinical trials. In our previous Study GL95-02, the group of patients that received Prestara had increased bone mineral density while the group that received placebo had reduced bone mineral density, and the difference between the groups was statistically significant."
Background on Genelabs' bone mineral density findings
Genelabs' Study GL95-02, which enrolled 381 women with lupus who received study medication for up to one year, contained a nested study of patients whose bone mineral density was measured at both the initiation and completion of the clinical trial. Thirty-seven of these patients were on trial medication for a full year, were treated with glucocorticoids for at least six months prior to the initiation of the trial, had a baseline bone mineral density measurement and a post-treatment bone mineral density measurement taken within one week of completion of the study. Data regarding these patients were presented to the Arthritis Advisory Committee in April 2001. In February 2002, we submitted additional analyses to the FDA from Study GL95-02 and additional published studies conducted by others. The GL95-02 analyses included all patients who had both baseline and post-baseline measurements of bone mineral density. In the analyses of GL95-02, mean bone mineral density of both the lumbar spine and hip significantly increased in the group of patients treated with Prestara, compared to decreases in the placebo group. The differences between groups were statistically significant favoring Prestara at both the lumbar spine (n=55, p=0.003) and hip (n=53, p=0.013).
"Musculoskeletal damage, including bone loss, is common among women with lupus, particularly those receiving glucocorticoids," said Kenneth Schwartz, M.D., vice president, medical affairs of Genelabs. "Early intervention to limit bone loss is important in the long-term management of lupus, and thus we believe Prestara can become a valuable addition for the care of these patients." |
