Calliditas läkemedelskandidat får snabbstatus från FDA

Läkemedelskandidaten setanaxib för behandling av en leversjukdom får Fast Track-status i USA.

By Tobias Bergman

August 9, 2021 3:32 PM

Setanaxib ska utvärderas för behandling av patienter med leversjukdomen primär gallkolangit (PBC). Setanaxib har tidigare beviljats särläkemedelsstatus för PBC i USA och Europa.

I en tidigare klinisk fas II-studie uppmätte man med läkemedlet en anti-fibrotisk aktivitet och en statistiskt signifikant inverkan på utmattning. Calliditas planerar att påbörja en fas 2/3-studie för PBC i år.

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