EMA re­views re­pur­posed ex­per­i­men­tal can­cer drug for Covid-19, even with­out a sub­mis­sion

In a rare move for any reg­u­la­tor, the Eu­ro­pean Med­i­cines Agency said Wednes­day it’s be­gun re­view­ing da­ta on the use of an ex­per­i­men­tal can­cer drug for treat­ing Covid-19, even though the Mi­a­mi-based spon­sor, Veru, has not sub­mit­ted an ap­pli­ca­tion.

The EMA re­view by its emer­gency task force fol­lows the re­lease of study re­sults ear­li­er this month show­ing the drug, known as sabiz­ab­u­lin, re­duced the risk of death by 55% in a study of 134 vol­un­teers hos­pi­tal­ized with Covid-19 who re­ceived sabiz­ab­u­lin and 70 who re­ceived place­bo. But ex­perts have been cau­tious about over­in­ter­pret­ing the re­sults, which were pub­lished in the NE­JM, par­tic­u­lar­ly as there have been very few ef­fec­tive treat­ments for those hos­pi­tal­ized with Covid.

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