AIFA drops proteinuria threshold from Fabhalta C3G registry for post-transplant recurrence
Italy's medicines agency has revised the Fabhalta monitoring registry, removing a blocking eligibility field for patients with recurrent C3 glomerulopathy after kidney transplant.
The Italian Medicines Agency (AIFA) has updated the monitoring registry for Fabhalta (iptacopan) in C3 glomerulopathy (C3G). The notice, dated 28 October 2026, follows publication of AIFA Determination No. 58/2026 in the Gazzetta Ufficiale No. 250 of 27 October 2026.
The registry covers treatment of adult patients with C3G in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are intolerant to RAS inhibitors or for whom such an inhibitor is contraindicated.
The specific change concerns the eligibility form. AIFA has removed the blocking field requiring a urine protein-to-creatinine ratio (UPCR) below 1 g/g, and proteinuria below 1 g/24 hours, for the population of patients with C3G recurring after kidney transplant.
AIFA reminded users that prescriptions relating solely to the indication reimbursed by the Italian National Health Service must follow the eligibility and prescribing-appropriateness criteria set out in the clinical form. The form can be downloaded as a .zip file from the list of active AIFA monitoring registries, accessible through the notice's related links.
What it means for your team
- Prescribing centres treating post-transplant recurrent C3G in Italy should check that they are using the updated eligibility form, as the UPCR and proteinuria blocking field no longer applies to this group.
- Market-access teams should note that registry criteria changed via Determination 58/2026, and align internal tracking of Fabhalta's reimbursement conditions in Italy.
- Reimbursed prescriptions must still follow the criteria in the clinical form downloaded from AIFA's list of active registries.
Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.
Market accessCompany releaseMedicare begins paying for Lucid's EsoGuard as PAVmed's Veris nears FDA 510(k) filing
Market accessOfficialDenmark updates Voltabak eye drop supply notice, with shortage expected to run to mid-May 2027
Market accessOfficialMethergin 0.2 mg/ml injection withdrawn from Danish market, DKMA reports
Market accessOfficialDenmark updates import window for estradiol 25 microgram patches in supply failure
Market accessOfficialDKMA updates Vivelle Dot 37.5 supply notice: shortage expected to last until end of December
Market accessOfficial