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Regulatory News | 14 July 2021 | By Michael Mezher
In its second untitled letter of 2021, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) flagged issues with Amgen’s promotion of its biological product Neulasta (pegfilgrastim) in a banner ad intended for healthcare professionals.
Neulasta is a leukocyte growth factor approved to decrease the incidence of febrile neutropenia (FN) in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs and to increase survival in patients exposed to myelosuppressive doses of radiation.
In an untitled letter dated 7 July, OPDP said the banner ad “makes false or misleading claims and representations about the benefits of Neulasta,” and that the product is misbranded, and its distribution violative, because of those claims. The untitled letter is the second issued by OPDP this year and follows a letter the office sent to Biohaven Pharmaceuticals over its promotion of Nurtec (rimegepant). OPDP has also sent two warning letters so far in 2021, one to AcelRx over its promotion of Dsuvia (sufentanil sublingual tablet) and one to CooperSurgical for a promotional video for its Paragard intrauterine device (IUD).
FDA specifically took issue with Amgen’s claims in the ad about the incidence of FN in patients taking Neulasta using Amgen’s Onpro on-body injector (OBI) compared to patients taking Amgen’s pegfilgrastim product delivered via pre-filled syringe (PFS).
The banner claimed that “In a Real-World Study with nearly 11,000 patients Pegfilgrastim PFS resulted in a significantly higher risk of FN vs Onpro.”
“These violations are concerning from a public health perspective because this promotional communication’s misleading claims could cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector (OBI) is more effective than Neulasta delivered via prefilled syringe (PFS) or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS,” FDA wrote.
Amgen also said the study showed that “FN incidence increased by 31% vs Onpro,” which FDA said could not be concluded from the study. “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 agency wrote.
FDA pointed out that the study was not designed to ensure that patients with FN were appropriately identified for inclusion in the analyses and that the study relied on an “unvalidated algorithm” to identify participants. Data provided by Amgen to OPDP “included no information about the performance characteristics (e.g., sensitivity, positive predictive value) of the algorithm or the diagnostic codes that were used.”
FDA notes that the study was not designed to adequately balance or control participants based on which delivery method that was used. “The study did not control for factors other than the delivery device that may influence the incidence of FN in the compared groups. Eligible patients for the study had highly diverse clinical characteristics, and the study report did not include any information on the baseline comorbidity or risk factors for FN of the two exposure groups or on design or analytic strategies to minimize the risk of selection bias,” the agency wrote.
Moreover, FDA knocked Amgen for reporting the relative effect observed in the study, noting that “the absolute difference is much smaller in magnitude (0.4%; 1.7% PFS vs 1.3% OBI).”
While Amgen did point out the limitations of the study in the seventh and eighth frames of the ad, FDA said the disclosure of the limitations “does not mitigate the misleading claims and presentations in the banner.”
FDA also took issue with Amgen’s framing of the two delivery methods as “Neulasta Onpro” or “Onpro” versus “Pegfilgrastim PFS.”
“The use of the proper name … of Amgen’s PFS product, on the one hand, and the proprietary name of its OBI product, on the other, could result in healthcare providers failing to understand that Amgen’s Neulasta was used in both arms of the study. Healthcare providers could conclude that a biosimilar pegfilgrastim product delivered via PFS is not as effective as Amgen’s OBI product,” FDA wrote.
Untitled Letter, Exhibit
Editor's note: This article has been updated to clarify the number of enforcement letters sent by OPDP in 2021.