eGFR-confirmed evidence, not a second accelerated approval on UPCR surrogate data, resolves payer caution in IgA nephropathy.

Budesonide (Tarpeyo, roughly 60% IgAN-specific share) and sparsentan (Filspari) are both marketed under FDA accelerated approval based on the UPCR proteinuria surrogate, with confirmatory eGFR-outcome data still pending. Of an estimated 150,000 US IgAN patients, 70,000-90,000 biopsy-confirmed, only 5,000-8,000 are on novel therapy today, a low penetration rate driven in part by payer caution around accelerated-approval status. Several major payers have already tightened UPCR thresholds beyond the FDA label pending confirmatory data, and some have signalled non-coverage risk if confirmatory trials disappoint.

The addressable near-term market is not the full IgAN population but the high-risk cohort, an estimated 15,000-25,000 US patients with UPCR above 1g/g and declining eGFR who have already been optimised on ACEi/ARB and, increasingly, SGLT2i. DAPA-CKD's IgAN subgroup showed a 41% ESRD-composite reduction. Nephrology KOLs have moved past UPCR as the practice endpoint; eGFR slope is what predicts ESRD prevention and what the specialist community actually uses to judge a drug.

Nephrology KOLs have already moved past UPCR as the practice endpoint that matters.

Five questions this report answers:

Q1 - Would a standard FDA approval on eGFR data outperform a second UPCR-based accelerated approval?

Q2 - How large is the high-risk, treatment-eligible IgAN cohort after ACEi/ARB and SGLT2i optimisation?

Q3 - What PA criteria and value benchmark should a new IgAN entrant plan for?

Q4 - What deliverable formats come with a commissioned US IgAN launch readiness assessment?

Q5 - How large is the treatment-eligible IgAN cohort a US launch should target?

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Live report page:  https://axlrx.ai/iga-nephropathy/launch-readiness/

Thanks & Regards,

Mike || Global Pharma Commercial Marketing Head

Email-     hello@axlrx.ai

Web-     https://axlrx.ai/