Azurity garners OPDP untitled letter for problematic emails
Marketing Xatmep (methotrexate oral solution) to health care providers without giving a full presentation of the drug’s serious risks has garnered Azurity Pharmaceuticals an untitled letter from the US Food and Drug Administration (FDA).In the letter dated 24 November 2019, FDA’s Office of Prescription Drug Promotion (OPDP) references promotional materials sent to healthcare professionals via email by Massachusetts-based Azurity.
Xatmep is indicated as part of a maintenance regimen for acute lymphoblastic leukemia (ALL) in pediatric populations, as part of a multiphase combination chemotherapy sequence. However, text in the email that was part of Azurity’s marketing campaign omitted significant parts of the specifics of this indication and usage, said OPDP in its untitled letter.
One statement which OPDP called misleading reads, “I wanted to let you know that Xatmep® (methotrexate) oral solution is available for your patients with Acute Lymphoblastic Leukemia.”
“This claim is particularly concerning because it suggests the drug is approved for use in patients of all ages without consideration for the necessity of other treatments as part of a combination therapy,” wrote OPDP.
The fact that the full indication occurred at the very bottom of the email, after the signature block, and in the Boxed Warning “does not mitigate the leading impression,” according to the agency’s letter. The letter from OPDP also notes that the Boxed Warning itself is not presented prominently enough, and that a signature block is, by convention, considered the end of the substantive content of an email correspondence.
Other information in Azurity’s marketing email also provoked OPDP concern. The email makes the claim that “2.5mg/mL provides easy dose titration as body surface area-based dosing is recommended,” but omits important warnings and precautions about the risks of improper dosing, including the fact that fatal toxicity has occurred when Xatmep was taken daily rather than once weekly, as it is meant to be dosed.
The untitled letter from OPDP notes that the agency had communicated similar concerns to Azurity, which was then known as Silvergate Pharmaceuticals, in June 2017. “Azurity appears to be promoting Xatmep without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP,” according to the untitled letter.
This misleading presentation of risk, said OPDP constitutes misbranding of Xatmep. Azurity is to provide a written response by 8 December 2020 with a list of all promotional materials that contain the violative representations, along with a plan for discontinuation.
OPDP