FDA grants de novo status to ‘5-minute’ drug monitoring tests for Humira, Remicade in IBD
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The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.
These are the first therapeutic drug monitoring tests authorized by the FDA for Humira (adalimumab, AbbVie) and Remicade (infliximab, Janssen) biologic therapies, in addition to the biosimilars Amjevita (adalimumab-atto, Amgen), Inflectra (infliximab-dyyb; Celltrion/Pfizer) and Renflexis (infliximab-abda, Samsung and Organon).
“Therapeutic drug monitoring of biologics is a useful tool in optimizing the care of patients with IBD and has become an accepted standard of care for IBD patients,” Adam Cheifetz, MD, professor of medicine and director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center/Harvard Medical School, said in the release. “Personalized dosing of biologics can improve outcomes. These first FDA-cleared tests for infliximab and adalimumab can improve access to TDM for patients by enabling immediate testing.”
According to the release, the Procise ADL and Procise IFX assays quantify drug levels of adalimumab or infliximab in patients with inflammatory bowel disease based on time-resolved fluorescence (Förster) resonance energy transfer immunoassays using the patented ProciseDx Analyzer and Lumiphore chemistry.
“Patients with [IBD] metabolize and respond to anti-tumor necrosis factor alpha biologics differently,” Niels Vande Casteele, PharmD, PhD, associate professor of medicine at the University of California, San Diego, said. “Measuring blood drug concentrations with an FDA-approved rapid assay at site of care presents a new opportunity to better understand sources of variability in drug pharmacokinetics and pharmacodynamics between patients. Performing TDM may help physicians understand why some patients respond or lose response to the treatment, which allows for a more personalized treatment.”
The release noted that drug monitoring testing can be performed onsite in moderately complex laboratories in hospitals or clinical laboratories.
“Currently, results for drug concentrations for infliximab and adalimumab take days and require shipment to expensive third-party laboratories,” Larry Mimms, PhD, CEO of ProciseDx, said in the release. “The ProciseDx platform will change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less.”
The company noted that it expects to commercialize these drug monitoring tests before the end of 2023. Additionally, during the upcoming ACG annual meeting, ProciseDx plans to present results from a benefit-risk analysis comparing ProciseDx TDM with empiric dose escalation in patients with secondary of response to infliximab.
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