BRIEF—FDA Priority Review for full approval of Calliditas' Tarpeyo

The US Food and Drug Administration (FDA) has accepted Swedish firm Calliditas Therapeutics’ submission for the supplemental New Drug Application (sNDA) and granted Priority Review for the full approval of Tarpeyo (budesonide) for the treatment of IgA nephropathy (IgAN).

The news pushed Calliditas’ shares up 4.4% to 91.75 Swedish kronor.

The sNDA is based on the Phase III NefIgArd trial, further reinforcing the potential of Tarpeyo to be disease-modifying.

Tarpeyo is currently marketed under accelerated approval to reduce proteinuria in adults with primary IgAN.

If granted full approval, Tarpeyo will become a treatment option for all IgAN patients, regardless of their disease progression levels, enabling physicians to proactively manage and potentially reverse the impact of the disease by targeting the source and slowing kidney function decline, says Calliditas.

The Prescription Drug User Fee Act (PDUFA) goal date in December 20, 2023.

Analysts have forecast that Tarpeyo, the company’s lead product candidate, could have global blockbuster potential, with peak sales in excess of $1 billion.