Medicines Healthcare Products Regulatory Agency
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IgA neuropathy, also known as Bergers disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in your kidneys.
Sparsentan was approved under the International Recognition Procedure (IRP), following route B.
The active ingredient in Filspari, sparsentan, works by blocking the receptors for two hormones called endothelin and angiotensin. Endothelin and angiotensin play a role in regulating processes in the kidney such as inflammation that lead to progression of kidney damage.
By blocking these receptors, Filspari lowers the amount of protein that leaks into the urine, and thereby helps to slow down progression of the disease
As with any medicine, the MHRA will keep the safety and effectiveness of sparsentan under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
ENDS
Notes to editors
- The new marketing authorisation was granted on 06 November 2024 to Vifor France under the International Recognition Procedure (IRP) Route B.
- The Reference Regulator (RR) was the European Medicines Agency (EMA), with the procedure number (EMEA/H/C/005783/0000).
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- For more information about IgA nephropathy, visit here
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal