Dyax Corp announced that the European Medicines Agency (EMA) has completed its validation process for the Marketing Authorization Application (MAA) for potential approval to market DX-88 (ecallantide) in the European Union (EU). The completion of this validation process signifies that the formal scientific review of the MAA has begun. DX-88 (ecallantide) has been approved by the US Food and Drug Administration (FDA) and is marketed as Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.
The EMA's review of the application will follow the centralized marketing authorization procedure. If approved, DX-88 (ecallantide) will receive marketing authorization in 27 EU member states.
"Starting the formal scientific review process with the EMA represents another step towards our global strategy of treating HAE patients outside of the United States," commented Gustav Christensen, president and chief executive officer of Dyax. "Dyax, along with our new strategic partner Sigma-Tau, looks forward to working with the EMA during this process as we seek approval in Europe."
Hereditary angioedema (HAE) is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in the larynx.
Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel biotherapeutics for unmet medical needs.