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SIGA Technologies submits NDA for oral smallpox treatment
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The health security company SIGA Technologies, Inc. announced today that it has submitted a new drug application for an oral formulation of TPOXX, an investigational antiviral for smallpox and other orthopoxvirus infections.
The development of TPOXX (tecovirimat) is funded by the Biomedical Advanced Research and Development Authority (BARDA). The new drug application (NDA) for tecovirimat is based on efficacy data from animal trials, as well as safety and dosing data from human clinical trials, according to a company press release. The use of animal data is permitted under the FDA’s “Animal Rule,” which allows efficacy endpoints to be assessed in animals when human efficacy trials are not ethical or feasible.
“Given that smallpox was eradicated in 1979, efficacy testing of TPOXX was not possible in humans,” Dennis Hruby, PhD, chief scientific officer of SIGA Technologies, told Infectious Disease News. “At an FDA Advisory Committee on Smallpox Antiviral development, three animal models were proposed: monkeypox in nonhuman primates, rabbitpox in rabbits, and ectromelia (mousepox) in mice. SIGA worked closely with BARDA to develop efficacy models and final efficacy testing in non-human primates and rabbits. These data will form the efficacy package to support use of TPOXX as a therapeutic in the event of an outbreak of smallpox.”
Although it is not yet approved, 2 million courses of the drug have been delivered to the Strategic National Stockpile through a contract with BARDA, the release said.
“Ensuring that critical medical countermeasures for smallpox are available in an emergency is an ongoing part of the U.S. biodefense strategy,” BARDA Director Rick Bright, PhD, told Infectious Disease News. “TPOXX has been supported by our colleagues at the National Institutes of Allergy and Infectious Diseases and the Department of Defense prior to transitioning to BARDA. The late-stage development and stockpiling of TPOXX through Project BioShield is the latest example of BARDA and private sector partners working together to address a serious biodefense threat.”
SIGA expects more information on the NDA’s review acceptance and a final action date in February. The company has requested an expedited review of tecovirimat.
“We are very pleased to have achieved this important milestone in the development of TPOXX. If approved, TPOXX would be the first-ever treatment for smallpox” Phil Gomez, PhD, chief executive officer of SIGA Technologies, said in the release. “Based on extensive positive efficacy data in animal studies and human clinical safety data without any drug-related serious adverse events, we believe the NDA for oral TPOXX is well positioned for favorable, expedited review by the FDA.” – by Stephanie Viguers
Disclosures: Gomez and Hruby are employees of SIGA Technologies, Inc.