The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the drug sparsentan, also known as Filspari, for the treatment of primary immunoglobulin A nephropathy (IgAN).
Renowned as IgA nephropathy or Berger’s disease, this kidney disorder arises when an antibody, immunoglobulin A (IgA), accumulates within the kidneys.
The approval for sparsentan was obtained under the International Recognition Procedure (IRP), following route B.
Sparsentan’s mechanism of action involves inhibiting the receptors of two hormones, endothelin and angiotensin, which are involved in regulatory processes in the kidneys such as inflammatory responses contributing to kidney damage.
By inhibiting these receptors, Filspari decreases the protein levels in urine, aiding in decelerating disease progression.
The MHRA will maintain rigorous monitoring of sparsentan’s safety and efficacy. Patients experiencing potential side effects should consult their healthcare provider and are encouraged to report these through the Yellow Card scheme available at https://yellowcard.mhra.gov.uk/ or via the MHRA Yellow Card apps on Google Play or Apple App Store.
The marketing authorisation, granted on the 6th of November 2024 to Vifor France, was facilitated through the International Recognition Procedure (IRP), Route B. This process was overseen by the European Medicines Agency (EMA), with the reference number EMEA/H/C/005783/0000.
The MHRA, responsible for the regulation of medicines and medical devices in the UK, ensures that the benefits of any medication outweigh the risks through comprehensive and data-driven assessments.
Operating as an executive agency within the Department of Health and Social Care, the MHRA remains committed to ensuring all medicinal products are effective and have an acceptable safety profile.