Results

AbbVie’s promised rheumatoid arthritis blockbuster upadacitinib hits its marks in another PhIII — this time without any deaths

AbbVie $ABBV has posted another positive batch of Phase III data on its JAK1 inhibitor upadacitinib, hitting the primary and key secondary endpoints in their pivotal program for rheumatoid arthritis. And this round of data comes without any new deaths in the drug arm to rattle investors and analysts.

Their drug — formerly ABT-494 — handily outscored a placebo, which was not unexpected. The therapy barely edged out Humira on ACR 20 at 12 weeks, but did much better on a range of endpoints like ACR50 (45% versus 29%) and clinical remission rates (29% versus 18%). Only 6% of the placebo arm experienced clinical remission.

AbbVie has been spotlighting this JAK1 program as one of its two top late-stage drug candidates with a mega-blockbuster future ahead for it. While their cash cow Humira has been freed of the threat of biosimilar competition to 2023, rivals are muscling in on its territory. The only way AbbVie achieves bigger revenue on Humira each year is by increasing its price.

Analysts following the drug breathed an audible sigh of relief at this latest post. Geoffrey Porges noted:

The total clinical experience of upadacitinib has now increased substantially without demonstrating a major risk for VTEs, which we believe reduces the risk of unexpected asset failure. After the recent failure of Rova-T in third-line small cell lung cancer, and the related drop in AbbVie’s stock value of >20%, the risk of a subsequent pipeline failure now also appears substantially reduced.

It’s a busy field. A Sanofi/Regeneron team won an approval for their IL-6 drug sarilumab (Kevzara) last year, as Gilead pushes ahead on their JAK1 filgotinib after AbbVie abandoned it in favor of its in-house program for upadacitinib. Eli Lilly is back up for a review of baricitinib, meanwhile, after the FDA reversed a decision to reject the drug without more data. But J&J was permanently shunted aside recently after the FDA spurned its application on sirukumab.

If it can gain a new approval on this drug, AbbVie execs are promising peak sales in the range of $6.5 billion a year, even though it faces plenty of competition.

AbbVie startled investors with news of the death of two patients in one study. And more recently investigators had to explain that another patient in the low-dose arm died of a hemorrhagic stroke caused by a ruptured aneurysm while there was also a case of pulmonary embolism in the same group. That followed a report in September that a patient taking a 30 mg dose experienced heart failure and presumed pulmonary embolism. In the most recent cases, both patients had already exhibited risks for these conditions, according to AbbVie.

AbbVie has also been hammered for some astonishingly bad data on Rova-T, a cancer drug it acquired in a jaw-dropping, $10.2 billion buyout deal for Stemcentrx two years ago.


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Molecular Templates Austin, TX
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Molecular Templates Austin, TX
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Flagship Pioneering Cambridge, MA

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