On the heels of un­prompt­ed EMA re­view of Covid drug, FDA sched­ules ad­comm for po­ten­tial EUA

The FDA is now fol­low­ing through on an emer­gency use fil­ing for a re­pur­posed can­cer drug that Eu­ro­pean reg­u­la­tors ini­tial­ly took an in­ter­est in.

The US agency said Wednes­day that it is con­ven­ing an ad­comm meet­ing of its Pul­monary-Al­ler­gy Drugs Ad­vi­so­ry Com­mit­tee, slat­ed for Oct. 6. The com­pa­ny be­hind the ad­comm is Veru, a Mi­a­mi-based biotech that orig­i­nal­ly start­ed out as a can­cer com­pa­ny.

The fed­er­al agency said in a pub­lic no­tice that as part of the ad­comm, one of the fo­cus­es of the ex­perts dur­ing dis­cus­sions will in­clude “the treat­ment ef­fect size in the con­text of the high place­bo mor­tal­i­ty rate, the lim­it­ed size of the safe­ty data­base, and iden­ti­fy­ing the pro­posed pop­u­la­tion.”

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