FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s out­side ad­vi­sors vot­ed in fa­vor of Fer­ring Phar­ma­ceu­ti­cals’ RBX2660, an ex­per­i­men­tal poop-based drug im­plant that the com­pa­ny says would be the first mi­cro­bio­ta-based live bio­ther­a­peu­tic to re­ceive an FDA green light.

That was a point re­peat­ed­ly dis­cussed dur­ing the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee, or VRB­PAC, meet­ing Thurs­day when eval­u­at­ing Fer­ring’s fe­cal mi­cro­bio­ta trans­plant, or FMT, for re­duc­ing the re­cur­rence of Clostrid­ioides dif­fi­cile in­fec­tion in adults who have re­ceived an­tibi­otics. Mul­ti­ple mem­bers brought up the need for a reg­u­lat­ed prod­uct amid a land­scape of un­reg­u­lat­ed FMTs al­ready hap­pen­ing in clin­i­cal care.

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