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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