The numbers from the lupus drug are at first glance quite inferior to those of fida. For example, "about 43.2 percent of patients receiving Benlysta experienced a reduction in symptoms after one year compared with 33.8 percent of those on a placebo. Over all, the F.D.A. estimated, about 11 patients must be treated with Benlysta for one to benefit."
And, "In a trial, there were more deaths and serious infections among those who received the drug compared with those on a placebo. However, this finding did not concern experts on the F.D.A. advisory committee."
Finally, "The companies said the price of Benlysta would be about $35,000 a year." Yikes! Want fries with that?
I remain optimistic and would welcome a significant pullback in share price to add. Also would not be surprised to see such occur after approval as many I believe hold the stock for that eventuality and will sell upon the approval, assuming a rise in price leading up to decision day.
Very good points. Publication in NEJM and design of study approved by FDA is no guarantee of approval.
Looking at the data on Xifaxan, Salix pharmaceuticals however, 11 patients of irritable bowel needed to be treated for one to benefit which I thought was not too robust when I read the study, which interestingly happens to be exactly similar to HGSI drug approval of BENLYSTA by the FDA. Bentlysta treated patients also had a higher risk of infections and death compared to placebo, yet was approved. Interestingly HGSA is only up less than 10 % since the FDA approval (jump of about 13% and down today 3.75%).
So no one can really predict how FDA will act, but I think the data on fidaxoxamin looks very good
"I never would have thought to compare a lupus drug to an antibiotic. Not even apples/oranges..."
Ahhh, doc, doc, doc.....c'mon, look at the larger picture. Not comparing the drugs themselves but the PROCESS. The FDA is willing to approve a drug with minimal superior efficacy compared to placebo, significant adverse reactions and high cost. Perhaps and likely motivated by understanding the need for something better than what is available. Compare to fida so far as efficacy, safety, and need.