US FDA Approves Monkeypox Treatment Formulation | Knobbe Martens


(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for an intravenous formulation of TPOXX (tecovirimat) for the treatment of smallpox. The United States, Canada and Europe have approved an oral formulation for the treatment of smallpox, and Europe has also approved it for the treatment of monkeypox and cowpox. The newly approved intravenous formulation provides an option for patients unable to swallow.

The approval is good news as more than 100 cases of monkeypox have been identified outside its endemic area. Australia, Belgium, France, the United Kingdom, Sweden, Italy, Spain, Portugal, Canada and the United States have reported cases. The World Health Organization (WHO) warns that more cases are likely.

Monkeypox is endemic to West and Central Africa and belongs to a subset of the Poxviridae family of viruses, which includes smallpox and cowpox. Symptoms of monkeypox (fever, sweating, headache, enlarged lymph nodes) are usually much milder than those of smallpox. The infection usually spreads from animals to humans. However, it can also be transmitted between humans. This can occur through contact with bodily fluids, lesions on the skin or on internal mucous surfaces, such as in the mouth or throat, respiratory droplets, and contaminated objects.

TPOXX is the first antipoxviral drug approved in the United States.

SIGA is the assignee of several patents relating to tecovirimat. These include the US patent. 8,124,643, 8,802,714, 9,862,683, 10,029,985 and 10,864,282.


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