FDA approves first drug with indication for treatment of smallpox

The US Food and Drug Administration approved TPOXX (tecovirimat) , the first drug with an indication for the treatment of smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes deadly infectious disease, eradicated in 1980, there is a long-standing fear that smallpox could be used as a biological weapon

"To fight against bioterrorism Congress has taken the opportunity to develop and approve countermeasures to counteract the pathogens that could be used as weapons. Today's approval is an important step in these efforts. This new treatment offers us an additional option if smallpox is used as a biological weapon, "said Scott Gottlieb, Commissioner of the FDA." This is the first product to receive a priority checklist on the Medical threat Today's action reflects the FDA's commitment to ensuring that the United States is ready for any public health emergency with medical products. x timely, safe and effective.

Before its eradication in 1980, the variola virus, mainly responsible for smallpox by direct contact between people. Symptoms usually started 10 to 14 days after infection and included fever, exhaustion, headache and back pain. A rash that initially consisted of small pink bumps evolved into wounds filled with pus before it crusted and left scars. Complications of smallpox can include encephalitis (inflammation of the brain), corneal ulcerations (open sore on the anterior surface of the eye) and blindness.

The efficacy of TPOXX against smallpox has been established by studies in animals infected with viruses. are closely related to the smallpox virus and were based on the measure of survival at the end of the studies. More animals treated with TPOXX lived compared to animals treated with a placebo. The TPOXX has been approved under the FDA's Animal Rule, which allows animal studies to be approved by the FDA when it is not feasible or ethical to conduct animal tests. efficacy trials in humans

. 359 healthy human volunteers without smallpox infection. The most commonly reported side effects were headache, nausea and abdominal pain.

The FDA has granted this application the Fast Track and Priority Review designations. TPOXX has also received the Orphan Drug Designation, which provides incentives to encourage and encourage the development of rare disease drugs and a medical countermeasure, which provides additional incentives for certain medical products to treat or prevent harmful

FDA granted TPOXX approval to SIGA Technologies Inc.

TPOXX was developed in collaboration with the Advanced Biomedical Research and Development Authority (BARDA) of the US Department of Health. health and social services.