Genelabs Prestara update
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genelabs plans to meet with FDA "to discuss the company's options with regard to the development of Prestara [prasterone] for lupus," the firm says June 22. Future development of Prestara also hinges on the outcome of an open-label extension study of a failed confirmatory trial looking at the agent's effect on bone mineral density. The trial is slated to complete in August 2005. "While [the study] may provide useful data on the effect of Prestara on bone mineral density of women with lupus over a longer period of time, the FDA normally does not consider such open-label studies to be sufficient to support approval of a new drug," Genelabs noted. La Jolla is currently conducting a confirmatory trial for its lupus agent Riquent (abetimus) (1Pharmaceutical Approvals Monthly November 2004, p. 13); Immunomedics' monoclonal antibody epratuzumab recently entered Phase III for the autoimmune disease...
You may also be interested in...
HGS Refines LymphoStat-B Lupus Trial Design After Phase II Misses Endpoints
Human Genome Sciences believes it can move ahead with Phase III trials of its systemic lupus erythematosus therapy LymphoStat-B but will refine the clinical study design - including clinical endpoints - from that used in Phase II
Riquent "Approvable" For Lupus; FDA Says Ongoing Study Could Be Enough
La Jolla Pharmaceuticals hopes running a parallel study alongside the ongoing confirmatory trial for its lupus agent Riquent will satisfy the requirements set out in FDA’s Oct. 14 "approvable" letter.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.