Human medicines European public assessment report (EPAR): Filspari, Sparsentan, Status: Opinion
Overview
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a conditional1 marketing authorisation for the medicinal product Filspari2, intended for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). The applicant for this medicinal product is Vifor France.
Filspari will be available as 200 mg and 400 mg film-coated tablets. The active substance of Filspari is sparsentan, a dual endothelin angiotensin receptor antagonist (agents acting on the renin-angiotensin system, ATC code: C09XX01). Endothelin 1 and Angiotensin II are central actors in the pathological cycle of IgAN and by inhibiting their receptors sparsentan can help decrease disease progression.
The benefit of Filspari is its ability to reduce proteinuria and slow down the progression of kidney disease, as seen in a phase 3, randomised, active-control (irbesartan) study in adults with IgAN. The most common side effects are low blood pressure, increase blood potassium levels, dizziness, swelling. The most common serious side effect is acute kidney injury.
The full indication is:
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).
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
1A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.
2This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained
CHMP summary of positive opinion for Filspari
First published: Reference Number: EMA/518075/2023
Product details
- Name of medicine
Filspari
- Active substance
Sparsentan
- International non-proprietary name (INN) or common name
Sparsentan
- Therapeutic area (MeSH)
Glomerulonephritis, IGA
- Anatomical therapeutic chemical (ATC) code
V03
- EMA product number
EMEA/H/C/005783
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
- Marketing authorisation applicant
Vifor France
- Opinion adopted
22/02/2024
- Opinion status
Positive
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