FDA chides Am­gen over mis­lead­ing ban­ner ad for Neu­las­ta

In its sec­ond un­ti­tled let­ter of 2021, the FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion raised ques­tions about Am­gen’s mis­lead­ing ban­ner ads for its block­buster bone mar­row stim­u­lant Neu­las­ta.

OPDP notes that cer­tain claims and pre­sen­ta­tions in the ads, which Am­gen said were di­rect­ed at health care pro­fes­sion­als, “cre­ate a mis­lead­ing im­pres­sion re­gard­ing the ben­e­fit of the prod­uct.”

For in­stance, Am­gen says in its ads that there is a sta­tis­ti­cal­ly sig­nif­i­cant high­er risk of febrile neu­trope­nia when Neu­las­ta is ad­min­is­tered via the pre­filled sy­ringe com­pared to its On­pro on-body in­jec­tor. “How­ev­er, the mul­ti­ple lim­i­ta­tions of the cit­ed study pre­clude the draw­ing of such con­clu­sions re­gard­ing the com­par­a­tive risk of febrile neu­trope­nia (FN) in pa­tients tak­ing peg­fil­gras­tim de­pend­ing on de­liv­ery method,” the FDA says.

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