The Allergenic Products Advisory Committee, an independent group of advisors, will help decide how to move forward in developing immunotherapies for curing allergic conditions.
With no specific products to review and no up-or-down voting questions, the agency’s Allergenic Products Advisory Committee heard from FDA officials and academic experts, who discussed a range of issues clinical trial design, appropriate end points, age-unique testing issues, and safety and efficacy for novel products aimed at asthma prevention and treatment and food allergies.
The panel spent a lot of time discussing the unique and challenging safety issues involved with testing and treatment of young children and infants.
“I can’t help worrying about traumatizing infants with immunotherapy,” one of the panelists said.
“Common adverse events may be too difficult to reliably detect and treat [in young children],” said Suyoung Tina Chang, MD, of the FDA Division of Vaccines and Related Product Applications.
Panel members worried that young children — an important population to try to treat — would be unable to articulate when they are experiencing symptoms such as pruritus, mouth edema, and throat irritation before anaphylaxis becomes life-threatening anaphylaxis. And that a lack of reliable data on trials involving infants and children under 5 would make it difficult to know where to set parameters.