Addendum To Luvox Post
FDA will be considering Luvox for COVID after all!
Scott provides updates on efforts to get FDA approval for fluvoxamine as a COVID-19 treatment and reports on the early approval of Paxlovid.
In my post yesterday, I quoted a Vox article describing work by Dr. Ed Mills and others to get the FDA to approve Luvox for COVID. As of that point, the FDA didn’t know how to process an application without a sponsoring drug company:
[Professor Ed] Mills, who thinks that fluvoxamine and budesonide are both appropriate to prescribe to patients sick with Covid-19, compares public messaging on fluvoxamine to communications about Merck’s drug molnupiravir. The evidence for molnupiravir is in many ways weaker than the evidence for fluvoxamine, but molnupiravir was produced by a major pharmaceutical company that can shepherd it through the process of becoming a recommended drug. On a call last week, Mills said, the FDA told him “they don’t know how to deal with submissions where there isn’t someone to be responsible for it.”
But it looks like just as I published, he and his colleagues found a way around the problem:
#IDTwitter we submitted EUA Application for #Fluvoxamine for #COVID19 to @US_FDA with the assistance of @EricLenze2 @AngelaReiersen @drklausner @ShohamTxID, and Ed Mills If you want to sign a letter of support forms.gle/3mDgxxgMgtVDNS… (names are not public & will be reviewed)
— David Boulware, MD MPH (@boulware_dr)
…though so far I’m having trouble figuring out their exact strategy:
Congratulations to the fluvoxamine team for figuring out how to make this (hopefully) work. If (and only if) you’re a medical professional with relevant credentials, you can add your name to the letter of support here.
The FDA also approved the other drug I’ve been saying they should approve quickly, Paxlovid, a full two weeks before the prediction markets expected! According to Metaculus, there was only a 6% chance we would get Paxlovid approved this quickly. They are genuinely getting better!
Thank you, FDA!