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Lusutrombopag FDA approved for thrombocytopenia in adults with chronic liver disease
By: News Feed | Last updated: 1st August 2018 | In: Haematology, Internal Medicine
CLD, FDA, lusutrombopag, Mulpleta, Shionogi
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).
The most common adverse reaction observed in ≥ 3% of patients treated with for lusutrombopag was headache. Learn more.
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
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