Slowing progressive chronic diseases requires substituting clinical endpoints with surrogate biomarkers.
To accelerate market access for progressive kidney and endocrine conditions, regulatory systems are clearing therapies based on early surrogate biomarkers, postponing final clinical verification.
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Vertex is pursuing accelerated drug approval for progressive kidney disease using early-stage surrogate biomarkers like UPCR and pathological antibodies.
The FDA leveraged accelerated approval based on a surrogate biomarker to delay pancreatic functional decline, requiring a follow-up trial to confirm real-world clinical efficacy.
The FDA accepted the surrogate biomarker C-peptide to accelerate the approval of Sanofi's therapy for newly diagnosed chronic diabetes, bypassing years of tracking long-term clinical endpoints.
Regulators cleared the chronic kidney disease therapy under the accelerated approval pathway using early surrogate markers instead of waiting for delayed eGFR endpoints.
Accelerated approval was granted for this progressive kidney disease by leveraging an early surrogate endpoint ahead of long-term validation.
Vera's IgAN drug secured market access using the early surrogate endpoint of proteinuria, with full status contingent on verifying long-term eGFR changes.