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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