The PEGylated erythropoietin biosimilar Omontys® (Peginesatide) was taken off markets by the companies Affymax and partner Takeda Pharmaceuticals last month because of cases of fatal anaphylactic reactions in 0.2% of the patients in the US. The companies work together with the FDA to resolve the problem. The most likely reason for pulling the product off the market is an unexpected allergic reaction of new patients against the product or a contamination, maybe due to certain production parameters. Until now, no statement about the exact nature of the problem has been published. In the wake of the event, Affymax had seen a loss of approx. 85% of its share value and is now facing potential lawsuits filed in the name of investors.
See the Affymax announcement here.
In principle it would be possible to detect such IgE-related allergic anaphylactic reactions and pre-test patients before receiving the first infusion of the drug. In addition, due to the non-emergency nature of this treatment there is no critical time restriction on the test, potentially allowing for more complex and sensitive testing. So, it is not surprising, that companies now start to use the event in marketing, as can be seen here.
PLS-Design has realized the problem long before the Omontys® tragedy, promoting component-resolved Companion Diagnosics for allergic patients. The focus of these tests is to prevent future anaphylactic reactions by optimized immunotherapy.
PLS-Design has cloned and expressed an array of recombinant insect venom allergens to test allergic patients and determine the pattern of allergic reactions. Some patients might show unexpected mono-sensitizations, whereas other show a more distributed allergy pattern. The reaction patterns will be used to optimize the composition and concentrations of allergens for improvement of the efficacy of immunotherapies.
See PLS-Design’s information about Companion Diagnostics (CDx) here.