AbbVie gets its FDA OK for JAK inhibitor upadacitinib, but don’t look for this one to hit execs’ lofty expectations
Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.
It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.
I asked for the 4-week cost breakdown for the new drug, but the spokesperson for AbbVie was sticking solely with that $59,000 figure.
AbbVie was widely expected to gain an approval, but there will be growing doubts about the drug’s ability to live up to execs’ high-flying expectations of megablockbuster sales in the $6 billion-plus range. Evaluate comes in at a far more modest — though still blockbuster — estimate of $2.5 billion in 2024.
This is part of AbbVie’s plan to design a future for itself after Humira loses patent protection in the US, though the company has won a reprieve with a number of analysts after striking a deal to buy Allergan and the Botox franchise.
Credit Suisse Evan Seigerman thinks the OK here with the black box will likely signal the same for Gilead’s filgotinib — partnered with Galapagos — when it arrives at the market in the near future.
We think that FDA could give filgo. a similar black box warning if appvd. Filgo. is likely to be competitive; however, GILD will need to be aggressive in marketing and contracting.
AbbVie gave up filgotinib and the rich licensing deal it had inked in favor of its program for upadacitinib.
Rheumatoid arthritis is a big and busy field. A Sanofi/Regeneron team won an approval for their IL-6 drug sarilumab (Kevzara). J&J was permanently shunted aside after the FDA spurned its application on sirukumab over safety concerns.
“Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis,” said Roy M. Fleischmann, primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas.
Social image: AbbVie