San Diego, USA-based Travere Therapeutics (Nasdaq: TVTX) and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).
Not withstanding the positive development, Travere’s shares were down more than 4% at $5.50 by late-morning trading. Filspari gained accelerated US regulatory approval more than a year ago.
The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
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