SIGA Technologies (SIGA) Receives FDA Approval for Intravenous (IV) Formulation of TPOXX

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May 19, 2022 7:32 a.m. EDT


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SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health safety market, today announced that the United States Food and Drug Administration (FDA) has approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox. The IV formulation is an important option for those unable to swallow TPOXX oral capsules.

“We are grateful to the FDA for their work that led to the approval of IV TPOXX, which will provide access to a broader patient population,” said Dr. Dennis Hruby, CSO of SIGA. “We are also grateful to our colleagues at BARDA who have worked with us for many years to include oral and IV TPOXX in prepping efforts in the United States and we look forward to continuing to work with them on our liquid pediatric formulation. “

The oral formulation of TPOXX (tecovirimat) is approved in the United States, Canada and Europe for the treatment of smallpox. The European approval also includes the treatment of monkeypox, cowpox and complications of vaccinia vaccination. The IV formulation of TPOXX was cited in the recent US President’s budget request as being used to treat a patient in the United States with monkeypox.


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