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UK MHRA Grants Marketing Authorization to Sparsentan for Immunoglobulin A Nephropathy

21 Nov 2024
Admin
News Article

UK MHRA Grants Marketing Authorization to Sparsentan for Immunoglobulin A Nephropathy

UK MHRA grants marketing authorization to sparsentan to treat adult patients with primary immunoglobulin A nephropathy

Overview

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the medicine sparsentan (Filspari) to treat primary immunoglobulin A nephropathy (IgAN).

Berger’s Disease

IgA neuropathy, also known as Berger’s disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in kidneys.

Sparsentan approval- Sparsentan was approved under the International Recognition Procedure (IRP), following route B.

Sparsentan: MOA

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.

Safety & Efficacy Analysis

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.

Marketing Authorisation –

The new marketing authorisation was granted on 06th 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).

The MHRA

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.