FDA approves first smallpox therapy to defend against bioterrorism

The FDA has announced that it has awarded marketing authorisation to SIGA Technologies’ TPOXX (tecovirimat) in the first approval of a drug specifically designed to treatment smallpox. But as the disease was wiped out in 1980, the motivation behind the decision is less conventional.

Rather than authorise the drug for the traditional reasons, the US regulator confirmed that the therapy had been approved as a defence in the event of bioterrorism.

"To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons," said FDA Commissioner Scott Gottlieb. "Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon."

"This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher," he continued. "Today’s action reflects the FDA’s commitment to ensuring that the US is prepared for any public health emergency with timely, safe and effective medical products."

The small-molecule antiviral treatment proved its effectiveness in 12 trials encompassing more than 700 participants, four of which demonstrated a significant reduction in mortality and viral load in non-human primates infected with monkeypox and rabbits infected with rabbitpox. The therapy also produced no serious adverse events in users.  

The approval decision follows a unanimous vote by an FDA advisory committee to recommend the use of the drug, agreeing that its benefits outweighed its risks.

"TPOXX is proof that public-private partnerships work when the partners are committed to a focused mission," remarked Dr Phil Gomez, Chief Executive Officer of SIGA Technologies. "The FDA approval of TPOXX achieves an important objective for both SIGA and our lead partner in the US Government, the Biomedical Advanced Research and Development Authority (BARDA).  The approval validates this novel smallpox therapy as an important medical countermeasure in response to a potential smallpox outbreak."

SIGA Chief Scientific Officer Dr Dennis Hruby also added: "We would like to acknowledge the efforts by everyone at SIGA and our many partners who have contributed to the development and approval of TPOXX. These partners include BARDA, the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control and Prevention, the Department of Defense (including the Defense Threat Reduction Agency and the US Army Medical Research Institute of Infectious Diseases), our academic and clinical collaborators, and our colleagues at the FDA."

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