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.
Among those limitations is Amgen’s use of an unvalidated algorithm with unknown performance characteristics and the fact that the study was not balanced or controlled for potential bias, the FDA notes. And while Amgen does note two limitations to the study, the agency adds that the mentions do not mitigate the misleading claims and presentations in the banner.
Because Neulasta biosimilars have also reached the market, these misleading claims may not just be limited to those using Amgen’s product.
“The above misleading claims and presentations are particularly concerning from a public health perspective because they could undermine confidence not just in Neulasta delivered via PFS but also in FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS,” the FDA said.
Amgen told Endpoints News in an emailed statement that it will work with the FDA to ensure it’s in compliance with the regulations. But the company also noted, “There is a robust body of clinical and real-world evidence that demonstrates that when used every cycle, Neulasta significantly reduced the incidence of febrile neutropenia (FN) as well as FN-related events, including FN-related hospitalization and the use of anti-infective drugs in patients undergoing chemotherapy.”
The use of untitled letters by OPDP has slowly become a thing of the past, especially when compared with the number of letters issued in the late 1990s, when the office routinely sent out more than 100 per year. Since 2017, however, the agency has only issued such untitled letters a handful of times annually, with 2 coming in 2017, 5 in 2018, 7 in 2019, and 2 for each of the last 2 years.