Shionogi’s Mulpleta (lusutrombopag) Receives FDA Approval for Chronic Liver Patients in Adults
Shionogi’s Mulpleta (lusutrombopag) Receives FDA Approval for Chronic Liver Patients in Adults
Shots:
- Mulpleta is approved based on two randomized, placebo-controlled trials (L-PLUS 1 & 2) involving 312 patients with platelets ≤50 x 109/L randomized 1:1 to receive 3mg once upto 7 days
- Oral recommendation is 3mg Q.D. with or without food for 7 days
- Results (Mulpleta vs PBO): In L-PLUS 1, No platelet transfusion (78% vs 13%) prior procedure; In L-PLUS 2, No platelet transfusion (65% vs 29%) prior procedure with common AE as headache