The FDA has sent its first untitled letter of 2025, hitting Edenbridge Pharmaceuticals with a notice after assessing an exhibit booth panel’s compliance with the rules on promoting prescription drugs.
Edenbridge, which rebranded as Dexcel Pharma in October, created the panel to communicate data on its multiple myeloma drug Hemady. The product is an oral formulation of the steroid dexamethasone. By including 20 mg of dexamethasone in each tablet, rather than the 4 mg found in some other products, the company has cut the number of pills multiple myeloma patients need to take.
The exhibit displays data on the claimed advantages of Hemady. However, the FDA, having reviewed the panel and a complaint made via the Bad Ad program, found fault with some information Edenbridge left out and the robustness of a study that underpinned some of the claims.
The panel’s omission of risk information is one focus of the FDA’s letter. The exhibit states that Hemady can cut the number of dexamethasone tablets multiple myeloma patients take by 80%. However, the panel is misleading, according to the FDA, because it presents those data but “entirely omits all risk information.” The agency said the lack of risk information creates a misleading impression about the safety of the drug.
The FDA also took aim at a retrospective, real-world comparison of adherence to Hemady and generic dexamethasone. Edenbridge presented the findings of the analysis in a table on the exhibit. The table compares the medication possession rate (MPR), a measure of adherence, and the percentage of people with an MPR of at least 80% for 4 mg dexamethasone and Hemady.
The ratio and percentage of patients with an MPR of at least 80% are higher in the Hemady cohort than in the 4-mg arm, according to Edenbridge. The company compared the cohorts, generating p-values of 0.0002 and 0.007. P-values of 0.05 and lower are typically considered statistically significant.
Yet, the FDA said the study “does not support conclusions regarding comparative adherence” to the two formulations because of design and methodology limitations. The agency listed problems with patient selection, noting that the study had failed to verify whether people on Hemady actually had been diagnosed with multiple myeloma and had included both newly diagnosed and relapsed or refractory patients in the 4 mg dexamethasone cohort, without distinguishing between the different phases of disease.
The FDA also highlighted the “notably unbalanced sample size”: The 4 mg dexamethasone arm contained 3,775 patients, but there were only 43 people in the Hemady group. The FDA said “such unbalanced sample sizes can lead to overestimation of adherence in favor of the Hemady group.”
Citing such issues, the agency said the study did not establish that adherence was better on Hemady than 4 mg dexamethasone.
The FDA sent the letter on Feb. 3 and gave Edenbridge 15 working days to respond. The agency asked Edenbridge to list all promotional communications that contain representations like those described in the letter.
The Hemady website for healthcare professionals used to display results from the adherence study, but Edenbridge removed that page some time after Dec. 3, 2024, per snapshots saved in the Internet Archive.