The Food and Drug Administration (FDA) has notified Amgen that a promotional communication related to Neulasta (pegfilgrastim) presents false and misleading claims about its benefit.

Neulasta is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome).

In an untitled letter, the Agency wrote that the promotional communication states that there is a statistically significant higher risk of febrile neutropenia when pegfilgrastim is administered through a prefilled syringe compared with delivery via the Neulasta Onpro on-body injector. These claims were based on an observational study that the FDA determined had “multiple limitations of design and analytic strategy.” 

“The promotional communication’s misleading claims and presentations could cause healthcare providers to conclude that pegfilgrastim delivered through the Onpro on-body injector is more effective than pegfilgrastim delivered through a prefilled syringe or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered through a prefilled syringe,” the FDA noted in a press statement.


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The Agency also expressed concern that such misleading statements could undermine confidence in the safety and effectiveness of FDA-licensed biosimilars and potentially slow the uptake of these products. Biosimilars to Neulasta include Fulphila, Nyvepria, Udenyca, and Ziextenzo.

Amgen has been given 15 days to respond to the letter and provide a plan to address these concerns.  

Health care providers are urged to report potentially false or misleading prescription drug promotion to the FDA’s Bad Ad program.

Reference

US Food and Drug Administration. FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit. Accessed July 14, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-notifies-amgen-misbranding-its-biological-product-neulasta-due-false-or-misleading-promotional.