Coronavirus Update: After Trump Pressure, US FDA Issues Emergency Use Authorization For Blood Plasma Therapy
Agency Reverses Decision
US FDA Commissioner Stephen Hahn cites 35% improvement in study, but critics are dismayed by fudging of science and political pressure.
You may also be interested in...
When the US FDA approved Olumiant (baricitinib) for RA, it insisted on a lower dose because of fears of blood clots. Now that an NIH trial has shown that the product plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized COVID patients, Olumaint may get an emergency use authorization from FDA to treat a condition that itself causes blood clots. That doesn't mean the black box is going away; it's just a reminder that there is as much magic and mystery to medicine sometimes as there is science.
Olumiant (baricitinib) plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized patients in US NIAID’s ACTT-2 clinical trial.
The deal would include an option for expansion to 160 million doses of the mRNA-based vaccine.