FDA approves Shionogi’s Mulpleta
The Food and Drug Administration has given the green light for Shionogi’s Mulpleta (lusutrombopag). The product is indicated for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
"We are very pleased the FDA has approved Mulpleta as a new, safe and effective treatment,” said Takayuki Yoshioka, Shionogi's president and CEO. “This new therapy offers physicians and patients another choice beyond platelet transfusions as adult patients with CLD often undergo procedures that could put them at increased risk for bleeding.
The product's approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 109/L. Patients were randomized 1:1 to receive 3 mg of lusutrombopag or placebo once daily for up to seven days.
"We are very pleased the FDA has approved Mulpleta as a new, safe and effective treatment,” said Takayuki Yoshioka, Shionogi's president and CEO. “This new therapy offers physicians and patients another choice beyond platelet transfusions as adult patients with CLD often undergo procedures that could put them at increased risk for bleeding.
The product's approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 109/L. Patients were randomized 1:1 to receive 3 mg of lusutrombopag or placebo once daily for up to seven days.