Immunoglobin A nephropathy (IgAN), also known as Berger’s disease, is a rare autoimmune disease of the kidneys that can, over 10 to 20 years, progress to end-stage renal disease. Clarivate forecasts the IgAN therapy market will grow at a CAGR of 26% to $4.2 billion in 2033, largely fueled by the emergence of novel therapies along with greater disease awareness and treatment rates, with patient populations projected to exceed 180,000 in the U.S. and 200,000 in the EU5. Until recently, treatment was strictly symptomatic, and there remains high unmet need for therapies that address kidney function decline, particularly those that more effectively lower UPCR and slow the decline in eGFR. The entry of TARPEYO® (budesonide) to the U.S. market in 2021 was a game changer. The drug, a delayed-release formulation of the corticosteroid budesonide from Calliditas Therapeutics in partnership with STADA Arzneimittel AG and Everest Medicines, is currently the only FDA-approved treatment for IgAN shown to significantly reduce the loss of kidney function – phase 3 trials showed 50% less damage to the kidneys compared to placebo over two years.

Full report : This small biotech notched a big win for rare disease patients with a canny market access strategy.