FDA ex­pands ap­proval of Agios' Tib­so­vo; As­traZeneca's long-act­ing di­a­betes drug se­cures US nod

→ Tib­so­vo is Agios’ first whol­ly-owned prod­uct, sec­ond ap­proved ther­a­py and the last drug that founder David Schenkein saw across the fin­ish line be­fore hand­ing over the reins to Jack­ie Fouse. Like the 2017-ap­proved Id­hi­fa, Tib­so­vo was cleared to treat re­lapsed or re­frac­to­ry acute myeloid leukemia (AML) — an ag­gres­sive form of blood can­cer — in pa­tients who car­ry an IDH1 mu­ta­tion. On Thurs­day, the prod­uct’s ap­proval was ex­pand­ed to in­clude adult pa­tients with new­ly-di­ag­nosed AML with a sus­cep­ti­ble IDH1 mu­ta­tion. “De­spite sev­er­al new AML med­i­cines ap­proved in the last two years, many new­ly di­ag­nosed pa­tients are still not el­i­gi­ble for ex­ist­ing ther­a­pies or com­bi­na­tion reg­i­mens be­cause of age and oth­er co­mor­bidi­ties,” said Agios $AGIO chief med­ical of­fi­cer Chris Bow­den said in a state­ment.

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