The Medicines and Healthcare products Regulatory Agency (MHRA)
has approved the medicine sparsentan (Filspari) to treat primary
immunoglobulin A nephropathy (IgAN).
IgA neuropathy, also known as Berger's 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