On the 31st of July 2018, the FDA approved lusutrombopag (Mulpleta®, Shionogi) for thrombocytopenia in adult chronic liver disease (CLD) patients scheduled for an invasive medical or dental procedure.

L-PLUS 1 and L-PLUS 2 Trials

The approval was based on two randomized, double-blind, placebo-controlled studies (L-PLUS 1 and L-PLUS 2, NCT02389621) in 312 CLD patients who received either lusutrombopag or placebo once daily for up to 7 days. All patients had severe thrombocytopenia (platelet count <50 x 10⁹/L) and were scheduled to undergo an invasive procedure.

In L-PLUS 1, 78% (38/49) vs 13% (6/48) of patients required no platelet transfusion prior to the primary invasive procedure for lusutrombopag vs placebo, respectively (95% CI, 49%-79%; p<0.0001).

In L-PLUS 2, 65% (70/108) vs 29% (31/107) of patients required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding from randomization through 7 days after the procedure for lusutrombopag vs placebo, respectively  (95% CI, 25%-49%; p<0.0001).

Safety

The most common adverse reaction observed in ≥ 3% of patients treated with for lusutrombopag was headache. Learn more.

Mulpleta® Full prescribing information.