The designation, announced by Sobi North America, gives pacritinib, a dual IRAK1/JAK2 inhibitor currently in Phase II trials, access to accelerated regulatory pathways intended for therapies targeting serious conditions with unmet medical need.
Lydia Abad‑Franch, Sobi’s Chief Medical Officer, said the FDA’s decision underscores the drug’s promise for patients who today lack approved treatment options.
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