Kalbitor approved for acute attacks of hereditary angioedema (HAE)

Kalbitor (ecallantide for injection, from Dyax) has been approved by the FDA for the treatment of acute attacks of hereditary angioedema (HAE) in patients ≥16 years of age. This approval was based on data from EDEMA3 and EDEMA4, two Phase 3, placebo-controlled clinical studies that evaluated the efficacy of Kalbitor in patients having an attack of HAE at any anatomic location, with at least one moderate or severe symptom. In both trials, the effects of Kalbitor were evaluated using the Mean Symptom Complex Severity (MSCS) score and the Treatment Outcome Score (TOS), two HAE-specific patient-reported outcome endpoints developed by Dyax.

Kalbitor-treated patients demonstrated a greater decrease from baseline in the mean MSCS than placebo (-0.8 vs. -0.4) and a greater mean TOS (53 vs. 8) in the EDEMA4 trial at 4 hours. In the EDEMA4 trial at 24 hours, Kalbitor treatment also resulted in a greater decrease from baseline in the mean MSCS than placebo (-1.5 vs. -1.1) and a greater mean TOS (89 vs. 55). The results in the EDEMA3 trial were consistent with that of EDEMA4.

Kalbitor will be made available in 10mg/mL single-use vials.

For more information call (888) 4KALBITOR or visit www.kalbitor.com.