FDA approves 1st drug to treat smallpox, in case of terror attack

Henrietta Strickland
July 16, 2018

The new drug was tested in animals infected with viruses that are closely related to the smallpox virus; however, it was not tested in people infected with similar viruses, the FDA said.

While smallpox was declared eradicated by the World Health Organization after a global vaccination campaign - meaning it no longer occurs naturally, explains Live Science - the disease still exists in the world, safeguarded in laboratory freezers for research purposes.

FDA commissioner Scott Gottlieb, MD, said tecovirimat provides more assurance versus public concern of potential bioterrorism involving smallpox.

With this approval, tecovirimat has become the first product to be awarded a Material Threat Medical Countermeasure priority review voucher, according to Dr Gottlieb.

To err on the side of caution and prevent a potentially lethal pandemic, as the disease spreads from person to person through direct contact, the FDA has now approved the first-ever smallpox drug.

"Today's action reflects the FDA's commitment to ensuring that the United States is prepared for any public health emergency with timely, safe and effective medical products", Gottlieb said. They received the drug and over 90% of the animals survived. Symptoms would usually start 10 to 14 days after the infection, including fever, exhaustion, and headaches.

Symptoms of smallpox are fever, fatigue, and sores filled with pus.

Complications commonly associated with smallpox include encephalitis, corneal ulcerations, and blindness. Rather, TPOXX was approved under the FDA's Animal Rule, which allows animal studies to be used to support approval when it is not feasible or ethical to conduct studies of the drug's effectiveness in people. The drug's safety was also tested on nearly 360 human volunteers, who did not have smallpox. Its application was previously granted Fast Track and Priority Review designations, and an Orphan Drug designation with its approval.

SIGA develops vaccines and medicines for biological, chemical, radiological and nuclear attacks. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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