Basic Information
Filspari
Regulatory Information
EMEA/H/C/005783
April 19, 2024
February 22, 2024
2
July 2, 2024
Company Information
92042 paris france
100-101 Terrasse Boieldieu Tour Franklin La Defense 8 Paris La Defense Cedex
Vifor France SASU
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion > 1.0 g/day (or urine protein-to-creatinine ratio > 0.75 g/g, see section 5.1).
Overview Summary
Filspari is a medicine used to treat adults with primary immunoglobulin A nephropathy, a disease where the kidneys gradually stop working and eventually fail, requiring patients to have dialysis (a process for removing unwanted substances or excess fluid from the blood) or a kidney transplant. Primary means that the cause of the disease is unknown. The medicine is to be used in people who have at least 1 g of protein in their urine per day or a urine protein-to-creatinine ratio of at least 0.75 g/g (another measure of protein levels in the urine). Filspari was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 October 2020. Further information on the orphan designation can be found on the EMA [website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2345). Filspari contains the active substance sparsentan.