Aurinia Pharmaceuticals Inc (AUPH)

[Whalatane]

Nephrologists will follow these guidelines
There are some positives here for Voc ( Lupkynis ) but these guidelines also limit the population likely to be prescribed Voc

5 A pooled analysis of the 2 trials showed that patients treated with voclosporin added to standard therapy had an RR rate of 44% at 1 year, compared to 23% in placebo patients (P < 0.0001).166
The incidences of adverse events were similar between the placebo and voclosporin arms.
Compared to other CNIs, such as cyclosporine and tacrolimus, voclosporin has a more consistent pharmacokinetic–pharmacodynamic relationship due to enhanced binding of the voclosporin–cyclophilin complex to calcineurin and reduced drug and metabolite load.
Preliminary evidence, based on data from the AURA-LV and AURORA trials, suggests that therapeutic drug monitoring is not necessary in the studied patient population.167 Note that there are no data on voclosporin given together with cyclophosphamide.
Results from the pivotal trials led to the U.S. FDA approval of voclosporin to treat adult patients with LN in January 2021.
Of note, voclosporin is not recommended for patients with a baseline eGFR <45 ml/min per 1.73 m2, and these patients were excluded from the trials.
Similarly, significant impairment of kidney function is often an exclusion criterion in clinical trials of CNIs.
The use of a CNI in patients with severe CKD requires careful individualized consideration of risk versus potential benefit, and should be done with caution and careful monitoring, and at reduced drug exposure.
The positive results of AURA-LV and AURORA coupled with those of the Asian studies of tacrolimus and cyclosporine suggest triple immunosuppressive therapy incorporating a CNI can be an effective treatment regimen for LN.
An advantage of a CNI-based regimen is the more rapid reduction of proteinuria.
However, outstanding issues on the duration of the CNI, its tapering and suspension, and the long-term efficacy and safety of CNI triple therapy regimens remain under study.

My wife knows of 2 patients prescribed Lupkynis for the highlighted reason above ......The ability to taper the steroids was an added plus. The limitation that surprised me was the recommendation for only those with a eGFR over 45 .

Kiwi