The European Commission (EC) has granted marketing approval for Shionogi’s lusutrombopag, for the treatment of severe thrombocytopaenia in adults with chronic liver disease (CLD), who are undergoing invasive procedures.
The approval is based on two pivotal Phase III randomised clinical trials, L-PLUS1 and L-PLUS2, in which the treatment meant that the patients needed no platelet transfusion prior to the primary invasive procedure, or rescue therapy for bleeding within seven days post-procedure.
As many as 75.5% of patients receiving lusutrombopag required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding within seven days post-procedure, compared with just 12.5% who received the placebo.
“Adult patients with advanced chronic liver disease often have to undergo invasive procedures for various medical reasons, but currently the only available treatment for TCP is supportive care with platelet transfusions. New and more effective pharmacological treatment options are urgently needed,“ said Professor Markus Peck-Radosavljevic, chairman at the Department of Gastroenterology & Hepatology, Endocrinology and Nephrology at Klinikum Klagenfurt in Klagenfurt, Austria.
“Lusutrombopag has convincingly demonstrated its efficacy and safety in raising platelet counts and avoiding platelet transfusions in clinical trials, and I welcome the EC’s decision to grant MA.”
CLD is a major public health issue, affecting approximately 29 million people in Europe, and is an increasing cause of morbidity and mortality worldwide. Thrombocytopenia is also the most common blood-related complication of CLD, occurring in up to 78% of patients with the condition.
The EU decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2018.