Shionogi wins European approval for novel therapy

22 February 2019

Japan’s Shionogi (TYO: 4507) has won European approval for lusutrombopag for the treatment of severe thrombocytopenia (TCP) in certain adult patients with chronic liver disease (CLD) undergoing an invasive procedure.

The safety and efficacy of the drug was demonstrated in two Phase III trials, LPLUS1 and L-PLUS2, in which the pre-specified primary and all key secondary endpoints were met with statistically significant results.

The therapy, which has already been approved for routine use in the USA and Japan, is a thrombopoietin receptor agonist (TPO-RA), a novel kind of treatment aimed at increasing platelet production through interaction with the TPO receptor.

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