Press release
SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of TPOXX® (tecovirimat)
- FDA approval provides an important option for those unable to take oral formulation of TPOXX - NEW YORK, May 19, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies,
About this update from Siga Technologies Inc.
[{"type":"text","content":"- FDA approval provides an important option for those unable to take oral formulation of TPOXX -\nNEW YORK, May 19, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox. The IV formulation is an important option for those who are unable to swallow the oral capsules of TPOXX. “We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population,” said Dr. Dennis Hruby, CSO of SIGA. “We are also appreciative to our colleagues at BARDA who have been working with us for many years to include oral and IV TPOXX in U.S. preparedness efforts and look forward to continuing to work with them on our liquid pediatric formulation.” The oral formulation of TPOXX (tecovirimat) is approved in the US, Canada and Europe for the treatment of smallpox. The European approval also includes the treatment of monkeypox, cowpox, and complications from immunization with vaccinia. The IV formulation of TPOXX was cited in the recent U.S. president’s budget request as being used to treat a patient in the U.S. with monkeypox. ABOUT SIGA TECHNOLOGIES, INC. and TPOXX® SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. Funding and technical support for this work is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. 75A50118C00019 (19C). For more information about BARDA, refer to https://www.medicalcountermeasures.gov/. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The ora...