Travere’s Filspari overcomes Phase 3 fail to become first drug for rare kidney disease

The FDA has greenlit Travere Therapeutics’ Filspari as the only available treatment for focal segmental glomerulosclerosis despite the drug’s loss to Sanofi’s Avapro in a Phase 3 study.

The FDA has given the go-ahead to Travere Therapeutics’ endothelin blocker Filspari for the treatment of focal segmental glomerulosclerosis, a rare and potentially fatal kidney disease that analysts expect could open a market opportunity over $2 billion.

“We expect launch to be strong due to urgency to treat this faster-progressing disease,” analysts at Jefferies wrote to investors on Monday evening, adding that Travere “already has an established commercial footprint.” Filspari was first approved in February 2023 for IgA nephropathy.

Jefferies also expects “limited competition” in the near future, with Travere enjoying at least a three-year headstart versus potential challengers such as BioMarin and Boehringer Ingelheim.

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