Posted by Michael Wonder on 03 Aug 2020
SIGA announces marketing authorisation filing for oral tecovirimat with the European Medicines Agency for multiple indications
30 July 2020 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications.
SIGA Technologies today announced that it has filed a marketing authorisation application with the EMA for oral tecovirimat, the same formulation that was approved by the U.S. FDA in July 2018 under the name Tpoxx.
The application was filed under the centralised application process, which, upon approval, and will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein.
SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection. SIGA is targeting approval for the second half of 2021.
