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US regulators defend requiring more data on monkeypox drug - SABC News - Breaking news, special reports, world, business, sport coverage of all South African current events. Africa's news leader.

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As US monkeypox cases rise, US health agencies in a medical journal article published on Wednesday defended their decision to require human trial data to show that SIGA Technologies’ experimental drug TPOXX is safe and effective to treat the virus.

Image: Reuters

The FDA approved TPOXX in 2018 for smallpox in adults and children based on studies of animals infected with monkeypox and rabbitpox, as well as safety data in healthy people. It can only be sold to the US Strategic National Stockpile. Although TPOXX was only tested in healthy people, the European Medicines Agency said it expects side effects to be similar in infected people, and deemed the drug’s benefits to be greater than its risks.

On July 21, the CDC and the FDA began allowing doctors to prescribe the drug before the trial paperwork is completed, but still requires approval of a hospital’s institutional review board for each dose.

이 소식을 빠르게 읽을 수 있도록 요약했습니다. 뉴스에 관심이 있으시면 여기에서 전문을 읽으실 수 있습니다. 더 많은 것을 읽으십시오:

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귀하의 의견에 감사드립니다. 귀하의 의견은 검토 후 게시됩니다.

Just watch SAns queue up to take TPOXX how crazy is that

Andizi

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