Japanese company Shionogi has received approval for Mulpleo (lusutrombopag) drug on the National Health Service (NHS) in England, Wales and Scotland to treat severe thrombocytopenia in adults with chronic liver disease (CLD).
The National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) provided positive recommendations for the drug in patients receiving invasive procedures.
Characterised by low platelet count, thrombocytopenia is the most common blood-related CLD complication. Oral treatments, such as lusutrombopag, are expected to offer various benefits for these patients.
Mulpleo is an oral agonist of thrombopoietin (TPO) receptor designed to induce the generation of endogenous platelets. The drug obtained European marketing authorisation in February.
Recommendations by NICE and SMC come from data of Phase III L-PLUS 18 and L-PLUS 29 clinical trials in 312 CLD patients with severe thrombocytopenia and a platelet count of less than 50,000 / µL.
Participants were set to undergo an invasive procedure and were treated with lusutrombopag or placebo once daily for seven days. Shionogi’s drug met the primary endpoint and all principal secondary endpoints.
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In L-PLUS 1 study, 79.2% of participants on the drug had not required platelet transfusion before the primary invasive procedure, compared to 12.5% on placebo. The percentage was 64.8% versus 29% in L-PLUS 2.
With lusutrombopag, platelet counts were maintained above 50,000 / µL for an average of 20.9 days in subjects not requiring platelet transfusion compared to 9.5 days with placebo in those requiring platelet transfusions.
Shionogi senior vice-president and market access global head Dr Mark Hill said: “We are delighted that both NICE and the SMC have recognised the value of lusutrombopag to treat severe thrombocytopenia in patients with chronic liver disease undergoing invasive procedures.
“It has demonstrated efficacy and tolerability in two pivotal Phase III trials, consistently raising platelet counts and avoiding the need for platelet transfusions.”
Mulpleo is already being marketed in Japan and the US to treat thrombocytopenia in CLD patients undergoing an invasive procedure.