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6.1.11 Conclusions
The application supports the efficacy of ecallantide 30mg for the proposed indication of the
treatment of acute HAE attacks in patient 18 years of age and older. The robust results of
EDEMA4 provide the primary support with additional support from EDEMA3. Repeat dose
data is limited given the lack of placebo control and the potential for selection bias, but the
submitted data combined with extrapolation of the single-dose, placebo controlled data supports
the efficacy of ecallantide for repeat, intermittent dosing.
The data for patients less than 18 years of age is limited. Although it is expected that
ecallantide would behave in a similar fashion in adolescent and adult patients, there is
insufficient representation of patients less than 18 years of age in the clinical program. The few
patients less than 18 years of age included in the clinical program are not sufficient to support the
efficacy of ecallantide in this age group.