Calliditas Files SNDA Seeking Full Approval Of TARPEYO - Quick Facts

(RTTNews) - Calliditas Therapeutics AB (CALT) announced the submission of a supplemental New Drug Application to the FDA seeking full approval of TARPEYO delayed release capsules for the entire study population from the Phase 3 NeflgArd study. The sNDA submission is based on the full data set from the Phase 3 NefIgArd clinical trial. It was developed under the project name Nefecon.

Calliditas noted that the company is collaborating with its European commercial partner, STADA Arzneimettel AG, to seek full approval of Nefecon by the European Commission in the full study population.

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