FDA Approves Drug To Treat Smallpox
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The U.S. Food and Drug Administration approved Tembexa (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon.

Because smallpox is eradicated, the effectiveness of Tembexa was studied in animals infected with viruses that are closely related to the variola virus. Effectiveness was determined by measuring animals’ survival at the end of the studies. More animals treated with Tembexa survived compared to the animals treated with placebo.

FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans. Safety information to support approval of Tembexa was derived from clinical trials of the drug for a non-smallpox indication, primarily from patients who received hematopoietic stem cell transplants.

An increased risk of death was seen in another disease when Tembexa was used for a longer-than-recommended duration. Tembexa is only approved for the treatment of smallpox. The most common side effects when using Tembexa are diarrhea, nausea, vomiting, and abdominal pain. Tembexa received priority review, fast track and orphan drug designations. Priority review directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.

Fast track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Orphan drug designation provides incentives to assist and encourage the development of drugs for rare diseases.

Source:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-treat-smallpox
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