Egetis slutför ansökan om godkännande i USA

Läkemedelsutvecklingsbolaget Egetis Therapeutics har slutfört sin rullande NDA-ansökan till den amerikanka läkemedelsmyndigheten FDA för Emcitate, en behandling mot den sällsynta sjukdomen MCT8-brist.

By Finwire / Life Science Sweden

January 29, 2026 8:22 AM

En NDA‑ansökan (New Drug Application) är en formell ansökan om att få ett nytt läkemedel godkänt för försäljning i USA.

Egetis har begärt prioriterad granskning och väntar regulatoriskt besked i september 2026. En lansering i USA väntas under fjärde kvartalet 2026, förutsatt godkännande.

Egetis Therapeutics har sedan i februari förra året ett godkännande i EU och en lansering skedde i Tyskland i maj samma år.

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