AbbVie gets a big boost in the major league rheumatoid arthritis finals with promising PhIII data

AbbVie passed on a big partnership it had set up with Galapagos on the promising rheumatoid arthritis drug filgotinib so it could focus all of its efforts on an in-house program for upadacitinib (ABT-494). And today the blockbuster gamble was rewarded with a round of stellar data from their first Phase III study of the oral JAK inhibitor.

Both the 15 mg and 30 mg doses swept the primary and secondary endpoints in the study, with 64% and 66% respectively hitting ACR20, with a minimum 20% improvement in the disease score.  ACR50 came in at 38% and 43%. Low disease activity was marked by about half of the patients while only 17% of the placebo arm could say the same.

Here’s the full chart:

There have been a host of major league rivals going after RA recently, with mixed results. So how does ABT-494 stack up?

At the top of the setback list is Eli Lilly’s baricitinib, partnered with Incyte, which the FDA rejected in April for largely unknown reasons. J&J and GlaxoSmithKline recently stumbled in a head-to-head with sirukumab against Humira, a mainstay in the market. The 50 mg and 100 mg sirukumab numbers hit 27% and 35% on ACR50 compared to 32% of the Humira group. But Regeneron and Sanofi scored with sarilumab (Kevzara), winning an approval for the IL-6 drug recently after being delayed over manufacturing issues.

AbbVie has high hopes for the oral upadacitinib, widely tapped as a blockbuster-to-be. It’s already well into a late-stage program on psoriatic arthritis followed by Crohn’s disease, ulcerative colitis and atopic dermatitis. And Geoffrey Porges at Leerink was quick to offer the company kudos for the way this therapy is being positioned. He noted:

The placebo-adjusted ACR20 benefit rates for upadacitinib with methotrexate of 28%-30% are numerically superior to competitor LLY (OP)/INCY’s (OP) baricitinib of 22-26% in the same trial with patients who had inadequate responses to DMARD, and the more stringent placebo-adjusted ACR50 and ACR70 rates for upadacitinib are also higher than seen in the baricitinib trial. We currently model $1.6bn in peak sales for upadacitinib compared to consensus expectations of $2.5bn in 2027E, and we believe that the superior data and recent FDA rejection of baricitinib favorably position AbbVie in the JAK market segment, and could lead to material upside to forecasts.

The pharma company was so pumped about its prospects with this drug, with peak sales projections running into the billions, that it walked away from its $150 million upfront on a rival oral therapy, which Gilead quickly scooped up for itself.

Gerd Burmester

“Achieving the target of low disease activity in nearly half of the patients by 12 weeks and doing so at both high and low dose levels is encouraging,” said Gerd Burmester, professor of medicine, Department of Rheumatology and Clinical Immunology, Charité Berlin, in a statement. “Current treatment recommendations recognize the importance of this clinical target for patients, as achieving low disease activity has remained an unmet need in rheumatoid arthritis.”

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Skyhawk Therapeutics Waltham, MA
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