New York based SIgA technologies announced today that the U.S. Food and Drug Administration (FDA) has approved tpoxx intravenous (IV) formula for the treatment of smallpox. In a press release released on May 19, 2022, SIgA said that for those who cannot swallow tpoxx oral capsules, intravenous formula is an important choice.
The oral preparation of tpoxx (tecovirimat) was previously approved in the United States, Canada and Europe. Tpoxx's global approval includes the treatment of smallpox, monkeypox, cowpox and complications of vaccine immunization.
Recently, SIgA announced that it had launched a clinical project to support the extension of oral tpoxx drugs to post exposure prevention.
From the perspective of supply, SIgA announced on May 12, 2022 that the U.S. Department of Defense (DoD) awarded SIgA a a contract to purchase up to about $7.5 million of oral tpoxx, of which about $3.6 million of oral tpoxx is scheduled to be delivered in 2022.
"We thank the U.S. Food and Drug Administration for its work in approving intravenous tpoxx, which will provide opportunities for more patients," commented Dr. Dennis hruby, CEO of sIgA in a related media statement. "We also thank our colleagues at BARDA, who have been working with us for many years to integrate oral and intravenous tpoxx into the prevention work in the United States, and look forward to continuing to work with them to develop our liquid pediatric preparations."
Smallpox is a highly contagious, disfiguring and often fatal disease that has affected humans for thousands of years. Monkeypox is caused by a member of orthopoxvirus in poxviridae. Smallpox vaccine has been confirmed to have cross protection against monkeypox virus to a great extent.