FDA announces approval of Shionogi's new drug Mulpleta (lusutrombopag) to market

Today, the U.SFDAannounced the approval of Shionogi'snew drugto treat specific groups of adult patients with thrombocytopeniaThese patients also suffer from chronic liver disease and have plans to undergo surgeryAbout Mulpleta
Mulpleta is an oral human platelet production (TPO) receptor agonist that combines with TPO receptors on the surface of macronuclecells to induce proliferation, differentiation, and maturation of these cells, thereby increasing platelet productionThis innovative therapy was approved by Japan's Ministry of Health, Labour and Welfare in September 2015 to improve the condition of lelett reduction in patients with chronic liver disease who have opted for invasive surgerythe study
in two randomized, double-blind, placebo-controlled clinicaltrial
(in which the researchers recruited 312 patients with chronic liver disease and thrombocyttosisThese patients are scheduled to undergo invasive surgery, but the platelet count is lower than 50 x 10 x 9 per litreThe patients were randomly divided into two groups, one receiving 3 mg of Mulpleta and the other receiving a placebostudies showed that 78% of patients in the first clinical trial no longer needed platelet infusions prior to surgery, a figure of only 13% (95% CI: 49%-79%, p 0.0001) in the control group; This figure is 65 per cent, compared with 29 per cent in the control group (95 per cent CI: 25-49 per cent, p0.0001)the new drug had previously been eligible for fast-track and priority review by the FDA and was expected to be returned on 26 AugustThe approval, which was approved nearly a month early, is a sign of the FDA's recognition of the safety and efficacy of the new drug