EC grants standard approval for Filspari in IgA nephropathy

The European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for Filspari (sparsentan).

Developed by CSL Vifor, a subsidiary of Australia’s CSL Limited (ASX: CSL), and Travere Therapeutics (Nasdaq: TVTX), Filspari is authorized for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

“The decision by the European Commission is an important advancement for people living with IgAN in the EU,” said Dr Vinicius Gomes De Lima, head of global medical affairs at CSL Vifor, adding: “The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe.”