Replies to post #17253 on Aurinia Pharmaceuticals Inc (AUPH)

[Whalatane]

Moose. I think it means they are recommending Lupkynis only for those that match the eGFR levels used in the pivotal trial.
Some Nephrologist might be using it " off label " as a last ditch effort for a patient with rapidly declining eGFR due to high levels of proteinuria .
eGFR is a measure of kidney function

eGFR, mL/min/1.73 m2
Mean (SD) 87.6 (29.5) 91.6 (29.8) 89.6 (32.8) 93.2 (29.8). ( this trial the eGFR was 87.2 for those with severe LN )
Serum creatinine, mg/dL
Mean (SD) 0.93 (0.33) 0.86 (0.31) 1.10 (0.96) 0.97 (0.79)
UPCR, mg/mg
Mean (SD) 5.9 (2.4) 2.1 (0.4) 2.3 (2.9) 1.0 (1.4)

So what this data is I think showing is that Lupy was effective at minimizing decline in eGFR while rapidly reducing UPCR ( protein in the Urine ) especially for severe cases .

I think the biggest problem for AUPH is the price they are charging for the drug and the push back via PA's required by the insurers ( Ie detail your patient has failed on all the other meds first )
JMO
Kiwi

[Whalatane]

Moose. I think this why they are limiting Lupy to the higher eGFR range .

. A reduction in eGFR was seen in 26 percent of the voclosporin group and 9 percent of the placebo group (although reductions in eGFR of >30 percent were found in an equal number of both arms of the study); most reductions were readily reversible. Hypertension was an adverse effect in 19 and 9 percent of the voclosporin and placebo groups, respectively.

JMO
Kiwi