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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A Backwards Approach: Expanded Access Drives Tpoxx Trial Design That Limits Placebo Control
US may be making common crisis-era mistake with Tpoxx trial design that prioritizes access over knowledge, ultimately restraining development of data needed to make the best treatment decisions with the potential Monkeypox treatment, particularly for the most vulnerable patients.
Monkeypox: Siga Says FDA Hasn’t Indicated Emergency Use Authorization An Option for Tpoxx
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.
Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos
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.