Benzinga | Jul 30, 2020 09:06AM EDT

SIGA Earlier Announced Marketing Authorization Filing For Oral Tecovirimat With European Medicines Agency For Multiple Indications

- Broader Indication to Include Smallpox, Monkeypox, Cowpox, and Vaccinia Complications -



NEW YORK, July 30, 2020 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that it has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for oral tecovirimat, the same formulation that was approved by the U.S. Food and Drug Administration (FDA) in July 2018 under the name TPOXX(r). The MAA was filed under the centralized 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.