All I have left of my SUPERNOVA clinical trial is just one phone call in November. I began to wonder if that meant I could see some early results.
Just as with my last trial, the drug has passed through a progression of names: code name to trial name to brand name. Just as FTy720 begat Fingolimod begat Gilenya, AZD3152 begat sipabivart and then ... nothing. No brand name yet.
But, back in June the European version of the Food and Drug Administration fast-tracked my drug because it is evidently so effective against Covid, including Omicron.
"Cool," I thought, "So why isn't the US FDA fast-tracking it?"
Why? Because they already fast-tracked the same drug from a different maker. That drug has a brand name, Pemgarda, and not only does it have a brand name it has a web site.
PEMGARDA has not been approved, but has been authorized for emergency use by FDA under an EUA, for pre-exposure prophylaxis of COVID-19
It has its own Wikipedia page too, under "Pemivibart". It's a US maker, Invivyd: I guess that's why the FDA picked it instead of MY FAR SUPERIOR drug.
I am quite pouty about it.
I'm sad I'm not going to get a chance to take a drug I helped make. (Well, along with 3,335 other guinea pigs.) However, just last month the FDA did add that Permgarda is the favorite only as long as it defeats the prevalent variant. That means there's a chance that my drug, Sipavibart, can still come from behind.
And of course, if not, then I am always happy to accept the thanks of a grateful Europe. Enjoy the fruit of my minimal labors.
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