Argenx, Calliditas Hit The Ground Running After FDA Approvals
Green Lights For Vyvant and Tarpeyo
Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.
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The Swedish biotech’s immunoglobulin A nephropathy therapy Tarpeyo is still selling well but “market access friction” is slowing growth. As US regulators grant a priority review to its data package for full approval, Calliditas’s prospects look promising.
Data from part B of the Swedish firm’s pivotal trial of Tarpeyo in the rare kidney disorder showed that the treatment effects lasted two years across the entire population, enabling the move from conditional to full approvals in several markets.
The Swedish group’s Tarpeyo is reaping the benefits of an expanded US sales force and the company is confident of a big revenue rise in 2023, regardless of new competition in the IgAN field from Travere’s Filspari.