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Regulatory News | 11 July 2018 | By Michael Mezher
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter—its third in 2018—to Arog Pharmaceuticals over promotional claims for its investigational drug crenolanib besylate, which is being developed to treat FLT3-mutated acute myeloid leukemia (AML).
In recent years, OPDP has seen a major drop in enforcement letters, culminating in a record low of just five warning and untitled letters sent to Orexigen Therapeutics, Cipher Pharmaceuticals, Magna Pharmaceuticals, Avanthi and the University of California Los Angeles in 2017. While OPDP has issued two other untitled letters so far this year, it has not issued any warning letters to drugmakers over advertising and promotion related issues.
The claims were made on Arog's booth display at the American Society of Hematology's (ASH) 59th Annual Meeting in December and on Arog's website, which FDA reviewed as recently as June 2018.
"The booth display and webpage suggest, in a promotional context, that crenolanib, an investigational new drug, is safe and effective for the purposes for which it is being investigated or otherwise promote the drug," FDA writes.
Specifically, FDA says the company's booth display and webpage claim crenolanib can be used to treat AML and FLT3-mutated AML.
At ASH, FDA says the company's booth display claimed that crenolanib combination therapy is the "future of AML treatment" and is "combinable with chemotherapy at full doses."
"This suggestion is especially concerning given the lack of adequate safety and efficacy data about crenolanib, as well as the toxicity of current chemotherapy regimens and issues regarding the tolerability of such regimens," FDA writes.
FDA notes that the company's claims that crenolanib is a "potent inhibitor" of FLT3 mutations, as patients with those mutations are more likely to experience relapse and tend to have decreased overall survival.
The booth display also did not indicate that crenolanib is an investigational new drug that has not been approved in the US.
Similarly, Arog made claims on its website regarding crenolanib's safety and efficacy for FLT3-mutated AML despite the investigational nature of the product.
"The conclusions made in these claims and presentations may create a misleading impression regarding the usefulness and approval status of this product. From a public health perspective, the claims and presentations are especially concerning given the seriousness of this disease and the relatively few available treatment options," FDA writes.
Due to these claims, FDA says that crenolanib is misbranded under the Food, Drug, and Cosmetic Act and requests that Arog immediately cease activities in violation of the Act. FDA also calls on the company to send a written response by 13 July stating whether the company intends to comply with the request and provide the agency with a list of all promotional materials for crenolanib that contain violative promotional statements.
Untitled Letter, Materials