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Topic - On M-pox
Posted: 21 Jan 2025 at 12:09am By Dutch Josh 2
https://flutrackers.com/forum/forum/welcome-to-the-scientific-library/poxviridae-including-monkeypox/1005223-in-a-%E2%80%98shocker%E2%80%99-decision-japan-approves-mpox-drug-that-failed-in-two-efficacy-trials-science-aaas or https://flutrackers.com/forum/forum/welcome-to-the-scientific-library/poxviridae-including-monkeypox/1005223-in-a-%E2%80%98shocker%E2%80%99-decision-japan-approves-mpox-drug-that-failed-in-two-efficacy-trials-science-aaas ;

In a ‘shocker’ decision, Japan approves mpox drug that failed in two efficacy trials - Science AAAS

17 JAN 2025. 6:50 PM ET​
BY JON COHEN

doi: 10.1126/science.zs6ktjw

On 2 January, Japan’s regulatory agency issued a news release that startled some scientists: It had approved the antiviral drug tecovirimat, also known as TPOXX, for the treatment of mpox and two cousins, smallpox and cowpox.

No treatments exist for mpox, a painful and sometimes fatal disease now raging in sub-Saharan Africa, and tecovirimat initially looked promising: It prevented death in monkeys given lethal doses of mpox and smallpox virus. The European Unionand the United Kingdom both approved it in 2022, after an earlier epidemic of mpox in men who have sex with men (MSM). At the time, the drug had been shown to be safe in humans, but no efficacy data existed. ...

link; https://www.science.org/content/article/shocker-decision-japan-approves-mpox-drug-failed-two-efficacy-trials or https://www.science.org/content/article/shocker-decision-japan-approves-mpox-drug-failed-two-efficacy-trials ;

But in the past 6 months, two such studies have definitively shown tecovirimat doesn’t work in people infected with either of the two clades of mpox virus. “To approve it now is very confusing,” says Jason Zucker, an infectious disease specialist at Columbia University who co-led one of the trials, the Study of Tecovirimat for Human Mpox (STOMP), which enrolled mostly MSM in the United States, Japan, Latin America, South Africa, and Thailand. “I am very curious to read studies used by Japanese [regulators] to approve it,” adds epidemiologist Placide Mbala of the Democratic Republic of the Congo’s (DRC’s) National Institute of Biomedical Research, who helped run the other trial, named PALM007. That study, in the DRC, tested the drug in children as well as adults and also found no benefit.

DJ, Money/profits ?

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