FDA Approved IV Formulation TPOXX For Monkeypox! Here’s The Safety Profile!

We have reported the side effects of the FDA-approved drug for smallpox, TEMBEXA. Even though there was a black-box warning, TEMBEXA got its FDA approval in 2021. But, now, the FDA approved another medicament with a suspicious safety profile.

SIGA Technologies, Inc, got approval for the intravenous IC formulation of TPOXX for treating smallpox and monkeypox. The approval was received on May 19.

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BioSpace reported:

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.

What about the side effects?

FDA document stated:

The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical [see Clinical Studies (14)]. TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models.

No adequate and well-controlled studies in pregnant women were conducted; therefore there are no human data to establish the presence or absence of TPOXX associated risk.

There are no data to assess the effect on milk production, the presence of the drug in human milk, and/or the effects on the breastfed child. When administered to lactating mice, tecovirimat was present in the milk (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TPOXX and any potential adverse effects on the breastfed child from TPOXX or from the underlying maternal condition.

There are no data on the effect of tecovirimat on female and male reproductive potential in humans. Decreased fertility due to testicular toxicity was observed in male mice [see Nonclinical Toxicology (13.1)].


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