Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All
Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.
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Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.
Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.
The UK says a “proportionate” approach to tackling monkeypox is needed, and that Imvanex is now available for vaccination. France has issued a decree authorizing the use of Imvanex and the importation of its US equivalent, Jynneos, and Germany has ordered thousands of doses of the vaccine. SIGA’s antiviral tecovirimat can also be used for monkeypox in the EU.