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Insulin treat patients The LixiLan-L trial [31] was a 30-week, double-blind trial, designed to confirm the superiority of IGlarLixi in comparison to glargine alone in patients with T2DM inadequately treated with a stable dose of insulin glargine and any other OAD

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Key takeaways include: eGFR slope over 2 years recommended as a primary endpoint for mildmoderate disease Proteinuria (UPCR) reduction may serve as a surrogate endpoint if it reasonably predicts long-term renal benefit Conditional approval may be considered, reflecting the lack of established disease-modifying therapies Early PMDA consultation is strongly encouraged to align trial design and endpoints This guidance brings Japan closer to global regulatory thinking and offers clearer pathways for efficient IgA nephropathy development programs

IV Therapies & Injections Medical treatments delivering nutrients and therapeutic agents directly into the bloodstream for rapid absorption and targeted health support