This article is part of the Arthritis Archives.
Dateline: April 22, 2001
New Lupus Drug Aslera
Genelabs Technologies filed a new drug application on September 26, 2000 for Aslera (also known as GL701 and prasterone), as a treatment for women with mild to moderate lupus, to better control the disease and its symptoms, and to decrease the need for corticosteroids. In October 2000, the U.S. Food and Drug Administration granted priority review status to the lupus drug developed by Genelabs.
Since Aslera would be the first new drug therapy approved for lupus in 40 years, the review has been highly anticipated. Priority review status is given to drugs which have potential to be more effective than current therapies. Once given priority review status, the drug candidate is reviewed within 6 months.
The FDA Arthritis Advisory Committee
The FDA Arthritis Advisory Committee met on April 19, 2001 and appeared split on whether to recommend approval of Aslera. The advisory committee makes recommendations but ultimately the decision is made by the FDA. Based on clinical study results, some committee members reportedly felt Aslera had "too many shortcomings" and was not obviously better than placebo. However, there are doctors who believe that since lupus patients are distressed over the lack of new treatment options, any benefit is significant. The committee did not actually vote on whether to recommend FDA-approval of Aslera, a synthetic version of DHEA (dehydroepiandrosterone), but clearly, their position was not unanimously favorable.
Some of the concerns regarding Aslera are addressed in "The Summary of the Pharmacology/Toxicology Review of Prasterone" by the FDA. On the flip side, advantages are pointed out in "The Clinical Rationale Behind Aslera and Clinical Trial Results" from Genelab. A decision by the FDA is expected by June 26, 2001. In the meantime, lupus patients remain hopeful.
Editor note: Aslera was later named Prestara. According to Prestara Clinical Trials from Genelabs Technologies, "In January 2006, Genelabs announced that the FDA had indicated that one additional, adequate, well-controlled phase III clinical trial would be necessary to support an indication for the treatment of the signs and symptoms of lupus. Separately, the FDA indicated that additional positive prospective phase III clinical trial data would be necessary before the FDA would consider reviewing an NDA for BMD in lupus. Based on this information, Genelabs plans to pursue an indication for treating the signs and symptoms of lupus and is in the process of designing a clinical trial protocol for an additional study, although the company does not believe that it will conduct the study on its own."
Related Resources - Prestara / Lupus
Sources: FDA Grants Priority Review For Genelabs' Lupus Drug Aslera, 10/26/00; Genelabs and Watson Report on FDA Advisory Committee Meeting for Aslera, Watson Pharmaceuticals, 4/19/01; Federal Advisory Panel Split On Lupus Drug Benefits, Reuters, 4/19/01
First published: 4/22/2001
