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news.Dyax has reported that the European Medicines Agency (EMA) is reviewing its marketing authorisation application (MAA) for a drug called DX-88 (ecallantide), following its validation process for the MAA for approval to market DX-88 in the EU.
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DX-88 (ecallantide) has been approved by the 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 centralised marketing authorisation procedure. If approved, DX-88 (ecallantide) will receive marketing authorisation in 27 EU member states.
Gustav Christensen, president and CEO of Dyax, said: “Starting the formal scientific review process with the EMA represents another step towards our global strategy of treating HAE patients outside of the US.
“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.”