Genelabs: Aslera
NDA has been filed for first line therapy for women with mild to moderate SLE to improve disease activity and/or its symptoms, and also to reduce corticosteroid requirements. Priority review. Advisory committee, originally scheduled in March, now set for April 19, 2001.
The NDA is based on data from 572 patients in two double blind, placebo-controlled, multicenter Phase IIIs; and includes data from a Taiwanese placebo-controlled clinical trial of 119 women. Company seems to say US studies met response endpoint, but in one (346 pts, couldn't locate the other) there is a huge placebo effect (66% drug vs 49% placebo), there was a trend in reduction of flares, and there is a lot in the PR about increasing bone density. Tolerable, but likely unpopular, se’s are acne, facial hair growth and hormonal changes. From what I can tell, the numbers are similar for those on steroids vs. drug-only. The Taiwanese study, showing reduction in flares, is with a slightly different formulation. I hope for the best and am sure there is much more to say in its favor that I have missed (like the other study), but it’s not astonishing that the short interest is well represented in gnlb shares. New SLE treatments badly needed.
--Wilder |
