U.S. FDA Approves Monkeypox Treatment Formulation

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By Mark Rubinshtein

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

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

Monkeypox is endemic to Central and West Africa and belongs to a subset of the Poxviridae virus family, which includes smallpox and cowpox.  Monkeypox symptoms (fever, sweating, headaches, enlarged lymph nodes) are generally much milder than smallpox.  The infection generally spreads from animal to human.  However, it can also be transmitted between humans.  This can occur through contact with bodily fluids, lesions on the skin or on internal mucosal 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 multiple patents relating to tecovirimat.  These include U.S. Pat. Nos. 8,124,643, 8,802,714, 9,862,683, 10,029,985, and 10,864,282.

Mark Rubinshtein
Mark Rubinshtein's practice focuses on patent litigation and prosecution for clients in the chemical and pharmaceuticals industries. Dr. Rubinshtein earned his J.D. at University San Diego School of Law. Prior to law school, Dr. Rubinshtein obtained a B.A in Chemistry and M.S. in chemical engineering from Columbia University and completed his PhD in organic chemistry in 2011 at UC San Diego. His graduate work focused on developing targeted small molecular therapeutics for Alzheimer's disease and on devising synthetic methods for the preparation of side-chain functionalized biodegradable and biocompatible polymers.
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