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Since the differences are small, it is reasonable to compare them at similar time points. Apart from the time of assessment, the two outcomes differed in the degree of allowable proteinuria (CR UPCR ≤ 0.5 PERR UCPR ≤ 0.7) and CR required sustained, low dose or no corticosteroid use.
#STOCKTWITS OMER TRIAL#
The primary outcome for the AURORA trial was “complete response” (CR) at one year, while the primary outcome in the BLISS-LN trial was “primary efficacy renal response” (PERR) at two years. Additional baseline characteristics for patients in all of the studies are in Supplement Table D4.3.There are several other important differences between the trials. The mean eGFR for patients at entry in the AURORA trial (91 ml/min) was slightly lower than that of patients in the BLISS-LN trial (100 ml/min) despite its exclusion of patients with low eGFR. Despite these differences, the patient populations in the two pivotal trials were otherwise quite similar (88% female, mean or median age 33, Black race 13-14% in both trials). Approximately 26% of patients in the BLISS-LN trial received cyclophosphamide. The primary differences in the study populations for the two drugs were that the AURORA trial excluded patients with an eGFR < 45 ml/min and required background therapy exclusively with MMF, whereas the BLISS-LN trial had no eGFR exclusion threshold and allowed background therapy with either MMF or cyclophosphamide (Supplement Table D4.2). From page 5 of the report (with my emphasis): Its analysis suggests that despite small differences in trials, the results are generally comparable. In the meantime, the Institute for Clinical and Economic Review (ICER) published a report entitled "Belimumab and Voclosporin for Lupus Nephritis: Effectiveness and Value". In my second article I noted that though it was difficult to compare results from disparate trials, LUPKYNIS would appear to be substantially more efficacious than Benlysta based on the following comparison table showing the percentage of complete responses at any given time interval:
#STOCKTWITS OMER UPDATE#
So today I'll review this development and its implications, update the comparison between the two new drugs and most importantly build a more rigorous initial valuation model for AUPH. Subsequent to those articles voclosporin / LUPKYNIS has been approved by the FDA with very positive labeling. I also compared (with caveats) the performance of voclosporin (now LUPKYNIS) versus GlaxoSmithKline's ( GSK) Benlysta, finding the former to be substantially more efficacious than the latter. In the second, I explained why I thought the partnership with Otuska was positive - not negative as the market generally believed. In the first, I dove into the company's prospective treatment for lupus nephritis and then offered an estimate of valuation based on a multiple of peak sales.
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Over the past six months I have written two articles on Aurinia Pharmaceuticals ( NASDAQ: AUPH).