UK MHRA Approves Sparsentan for IgA Nephropathy Treatment

The MHRA in the UK has given the approval to sparsentan (Filspari) for the treatment of IgAN. Berger's disease, or IgA neuropathy, is a kidney condition caused by the accumulation of immunoglobulin A (IgA) antibodies in the kidneys.

Sparsentan was authorized through the International Recognition Procedure (IRP) via route B. The primary component in Filspari, sparsentan, functions by inhibiting the receptors for two hormones known as endothelin and angiotensin. Endothelin and angiotensin are involved in controlling kidney processes like inflammation that contribute to the advancement of kidney injury.

By obstructing these receptors, Filspari reduces the protein leakage into the urine, thus aiding in the delay of disease progression. Vifor France was granted a new marketing authorization on November 6, 2024 through Route B of the International Recognition Procedure (IRP). The European Medicines Agency (EMA) served as the Reference Regulator (RR) with the procedure number (EMEA/H/C/005783/0000).

The MHRA oversees the regulation of medicines and medical devices in the UK to ensure they are effective and safe for use. All of our efforts are supported by strong and evidence-based decisions to make sure the advantages outweigh any potential risks. The MHRA is a branch of the Department of Health and Social Care that operates as an executive agency.