Ireland-headquartered Shire (LSE: SHP) today announced that the US Food and Drug Administration has granted the company Fast Track designation for its rare disease candidate SHP655.
The candidate therapy is being developed to treat hereditary thrombotic thrombocytopenic purpura (hTTP), a life-threatening congenital disease caused by an enzyme deficiency.
The designation is supported by preclinical data and a Phase I study involving 15 patients, in which no serious adverse events were reported.
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