FDA mulls parameters for allergy therapies

With rising rates of allergic conditions in children, FDA recently assembled a panel of independent advisors to present ideas for moving forward with the development and improvement of immunotherapies for curing these conditions.

With rising rates of allergic conditions in children, FDA recently assembled a panel of independent advisors to present ideas for moving forward with the development and improvement of immunotherapies for curing these conditions. FDA officials and academic experts discussed issues including clinical trial design, appropriate endpoints, age-unique testing issues, and safety and efficacy for novel products aimed at asthma prevention and treatment and food allergies. The panel dedicated a large part of the discussion to the unique and challenging safety issues involved with testing and treatment of young children and infants—one panelist voiced concern about traumatizing infants with immunotherapy, and others worried that young children would be unable to articulate their symptoms of anaphylaxis. Food allergy was another key topic of discussion. Kathleen Hise of FDA's Division of Vaccines and Related Product Applications suggested a potential alternative to food challenge with field trials that have a primary endpoint of reduction of rate or severity of reactions to accident. Hise added that biomarkers could serve as allergen specific surrogate endpoints.