Smallpox treatment: Smallpox can no longer be used as a biological weapon; a new drug gets approval from the USFDA



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WASHINGTON: The US Food and Drug Administration (FDA) on Saturday approved the first drug with an indication for the treatment of smallpox.

Smallpox, an infectious contagious and sometimes fatal disease, was declared eradicated in 1980 by the World Health Organization. However, there have long been concerns that smallpox could be used as a biological weapon.

TPOXX (tecovirimat) is a small molecule antiviral treatment for smallpox, the first therapy specifically approved for this indication.

"To counter the risk of bioterrorism, Congress has taken steps to allow the development and approval of countermeasures to counteract the pathogens that can be used as weapons." "Today is a milestone in these efforts." If smallpox was to be used as a biological weapon, Scott Gottlieb, the FDA's Commissioner, said in a statement.

The approval "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," he added. .

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The efficacy of TPOXX against smallpox has been established by studies in animals infected with viruses closely related to the smallpox virus.

More animals treated with TPOXX lived compared to animals treated with placebo.

In addition, the safety of TPOXX was also evaluated in 359 healthy human volunteers without smallpox infection. The most commonly reported side effects were headache, nausea and abdominal pain.

TPOXX also received the Orphan Drug Designation, which provides incentives to encourage and encourage the development of drugs for rare diseases and a medical countermeasure, which provides additional incentives for certain medical products intended to treat or treat prevent specific damage. chemical, biological, radiological and nuclear threats, according to the statement.

The FDA granted TPOXX approval to SIGA Technologies Inc., a New York-based pharmaceutical company, and will initially be available only through the US Government's Strategic National Stockpile (SNS).

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