FDA hustles through a quick OK for Shionogi's new thrombocytopenia drug
The FDA has whisked through a new drug for thrombocytopenia patients.
The therapy is lusutrombopag (Mulpleta), which handily beat the August 26 PDUFA date that the FDA had handed Shionogi when it accepted the drug for a priority review schedule back in February.
The drug is approved for use in thrombocytopenia patients — characterized by low platelet levels — with chronic liver disease who are about to undergo an invasive, scheduled medical or dental procedure. The drug proved itself in two studies in which a large majority of the patients — 78% and 65% — required no transfusions ahead of procedures after getting the drug, compared to much smaller groups in the placebo arms.
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