U.S. FDA Approves Expanded Smallpox - Monkeypox Treatment Formulation

New York-based SIGA Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of TPOXX for the treatment of smallpox.

SIGA stated in its press release issued on May 19, 2022, that the IV formulation is an essential option for those unable to swallow the oral capsules of TPOXX.

The oral formulation of TPOXX (tecovirimat) is approved in the U.S., Canada, and Europe.

TPOXX worldwide approvals include the treatment of smallpox, monkeypox, cowpox, and complications from immunization with vaccinia.

Recently, SIGA announced that it had initiated clinical programs to support oral TPOXX label expansion for Post-Exposure Prophylaxis.

And from an availability perspective, SIGA announced on May 12, 2022, that the U.S. Department of Defense (DoD) awarded a contract to SIGA for the procurement of up to approximately $7.5 million of oral TPOXX, of which approximately $3.6 million of oral TPOXX targeted for delivery in 2022.

“We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population,” commented Dr. Dennis Hruby, CSO of SIGA, in a related media statement. 

“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.”

Smallpox is a contagious, disfiguring, and often deadly disease that has affected humans for thousands of years. And monkeypox is caused by a member of the Orthopoxvirus genus in the family Poxviridae.

As of May 19, 2022, six countries have reported monkeypox cases in May 2022.

Breaking news is posted at Vax-Before-Travel.com/Monkeypox.

Note: The SIGA announcement was edited for clarity and manually curated for mobile readership.