After seven people died in 2013 from serious allergic reactions to Omontys, an injectable anemia drug marketed by Takeda Pharmaceutical (TYO:4502) and Affymax, the companies recalled the product and regulators launched an investigation to find out the cause of such an unexpected rate of anaphylaxis.
Omontys was made and cleared in a single-use vial and a multi-use vial, which sported different formulations. The companies used the single-use vial’s formulation in clinical trials but only marketed the multi-use vial.
Using an imaging system from Fluid Imaging Technologies, the FDA was able to evaluate the chemical composition of Omontys and discovered that the multi-use vial’s formulation had a significantly higher concentration of subvisible particles compared to the single-use vial.
Although the FDA didn’t establish a causal relationship between the particulates and the rate of anaphylaxis, Fluid Imaging Technologies CEO Kent Peterson told Drug Delivery Business News that the case study further highlights the importance of visualizing and characterizing a drug product’s composition early in the development process.