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Whenever the FDA approves a drug, companies usually tout the patient population that it will help. However, this is not exactly the case for the most recent approval to the FDA
Phil Gomez
Tecovirimat, or Tpoxx, treats smallpox, an often deadly infectious disease that has been declared eradicated in 1980 by the World Health Organization. But the strains of the virus that causes the disease still exist – there are two known samples stored in laboratories in Russia and the United States, and at least one previous discovery of forgotten vials – which, once unleashed, could cause a pandemic lethal. Add to that the possibility that terrorists can rebuild the virus by using gene editing techniques, and disaster scenarios abound.
Regulators have made it clear that the risk of bioterrorism is the main concern here.
Additional option should smallpox ever be used as a biological weapon, "said FDA Commissioner Scott Gottlieb in a statement. "This is the first product to receive a good priority review on the medical countermeasure." Today's action reflects the FDA's commitment to it. " to ensure that the United States is ready for any public health emergency with timely, safe and effective medical products. "
To prove the effectiveness of the pill in the absence of smallpox with monkeypox and the rabbit – both induced by viruses closely related to the smallpox virus responsible for smallpox In total, they conducted four trials in non-human primates and two in rabbits
The FDA liked the survival data, as well as the safety profile demonstrated by a trial involving 359 healthy human volunteers
.Siga Technologies, which had teamed up with the Biomedical Advanced Research and Development Authority (BARDA) on the project and is now eligible to receive 41 million dollars.
"Approval validates this new smallpox therapy as a major medical countermeasure in response to a For now, Tpoxx will only be available through the Government's Strategic National Stockpile American, which already has 2 million courses of oral therapy.
It could change like New York. Siga is exploring additional indications for the drug, including monkeypox, which also infects humans.
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