The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance endorsing the use of CSL Vifor’s Filspari (sparsentan) within the National Health Service (NHS) in England for treating adult patients with primary immunoglobulin A (IgA) nephropathy.
The recommendation applies to those with a urine protein excretion of at least 1g/day or a urine protein-to-creatinine ratio of 0.75 g/g or above.
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NICE’s guidance stipulates that treatment continuation should be based on patient response, following the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) authorisation in April 2025.
Sparsentan is expected to be funded in England by 27 June 2025, within 90 days of the final guidance publication.
IgA nephropathy is a kidney condition caused by the accumulation of faulty immunoglobulin A in the glomeruli, leading to kidney damage.
Developed by Travere Therapeutics, sparsentan received orphan drug designation for treating this condition in Europe, the UK and the US and is already available in the US and some European markets.
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By GlobalDataCSL Vifor holds exclusive rights to commercialise sparsentan in Australia, New Zealand and Europe.
The therapy will be available to UK patients in the second half of 2025. As a non-immunosuppressive treatment, sparsentan targets both the endothelin A receptor and the angiotensin II subtype 1 receptor, which are implicated in kidney inflammation and damage.
The recommendation from NICE is grounded in outcomes from the Phase III PROTECT trial, which assessed the efficacy and safety of sparsentan 400mg against 300mg of irbesartan >400 adult patients with IgA nephropathy and persistent proteinuria.
CSL Vifor global medical affairs head Dr Vinicius Gomes De Lima stated: “We are very pleased that NICE recognised the value of our innovative therapy which helps to address a clear unmet medical need in patients with IgA nephropathy.”
In January 2024, Travere entered a licensing agreement with Japan’s Renalys Pharma to extend sparsentan’s reach to several Asian countries.
