Travere lines up another shot at speedy sparsentan approval

 In May the FDA knocked back Travere’s attempt to win accelerated approval for sparsentan in focal segmental glomerulosclerosis, demanding more data. Encouraging early results in another rare kidney disease, IgA nephropathy, have persuaded the company to try again. A first-half 2022 filing is planned, backed by interim data from the Protect trial, which found a statistically significantly greater reduction in proteinuria, a biomarker used to track the disease, in patients treated with sparsentan versus irbesartan, a long generic hypertension medication. Sparsentan also reduces blood pressure but is mechanistically different from irbesartan and other anti-hypertensives used off-label for IgAN. No data were disclosed on estimated glomerular filtration rate (eGFR), a kidney function endpoint that must be hit for full approval; on a call executives said preliminary eGFR details were “consistent with our powering and indicative of a clinically meaningful result”. Is this is enough for the FDA? The project looks competitive with Calliditas’s steroid-based Nefecon, due an accelerated approval decision in IgAN in September; that filing did include eGFR data. Cross-trial comparisons are always imperfect, but with nothing approved for IgAN perhaps the most important point here is that both look effective.

IgAN rivals? Cross-trial comparison of Nefecon and sparsentan
	Calliditas, Nefigard part A: Nefecon vs placebo		Travere, interim readout from Protect: sparsentan vs irbesartan
Endpoint	Nefecon 16mg	Placebo	Sparsentan 400mg	Irbesartan 300mg
Mean reduction in proteinuria vs baseline*	31%	5%	49%	15%
Change in eGFR**	0.17ml/min/1.73m2 decline	4.04ml/min/1.73m2 decline	?	?
Note: Nefigard patients remained on existing hypertensive medication; Protect patients were switched to sparsentan or irbesartan, and steroid use excluded.  *Measured at 9 mths in Nefigard and 36 wks in Protect; **Measured at 9 mths in Nefigard, to be measured at 1 yr+ in Protect. Part B of Nefigard will provide long term data for full approval. Source: company releases & clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/snippets/travere-lines-another-shot-speedy-sparsentan-approval