Lilly’s Olumiant Could Get Blood Clot Redemption With EUA For COVID
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.
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Weeks after FDA authorized emergency use of its antibody bamlanivimab, Lilly’s RA drug Olumiant can be used to shorten recovery time for hospitalized COVID-19 patients in the US. Authorizations are being pursued elsewhere as well.
The European Medicine Agency has recommended extending the therapeutic indication of a raft of drugs that are already authorized in the EU.
Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.