AbbVie hits all endpoints for rheumatoid arthritis test; analyst says $3.5B peak ‘too low’

This comes after a rival Lilly/Incyte candidate was hit with an FDA knockback in April.

AbbVie says its investigational rheumatoid arthritis (RA) drug upadacitinib bested placebo in reducing symptoms of the disease, as analysts at Jefferies says its $3.5 billion peak sales estimates may be too low.

The data, posted this morning, show that two doses of the oral JAK1-selective inhibitor created a statistically significant cut in symptoms in pretreated patients when compared to a dummy treatment in the 12-week, phase 3 test.

Around half of patients saw a low disease activity at both doses (48% of patients receiving either dose of upadacitinib, compared to 17% of patients on placebo) hitting its primary endpoint, with around 30% achieving clinical remission across both doses, compared to 10% for the dummy pill. Safety also seemed to be promising, with no surprises coming over since phase 2 testing.

This med, alongside other JAK inhibitors, are looking to rival injected biologics, which includes Amgen’s Enbrel and AbbVie’s own major $14-billion-a-year Humira. Pfizer's Xeljanz, an oral JAK inhibitor, brought in almost $1 billion in 2016.

This is especially welcome news for AbbVie as it comes after Eli Lilly and partner Incyte saw their JAK med drug, Olumiant, rejected by the FDA amid requests for more safety data. It has however been approved in Europe.

RELATED: FDA stuns Lilly and Incyte with CRL for much-anticipated RA drug baricitinib

Upadacitinib is also in test for psoriatic arthritis, Crohn’s disease, ulcerative colitis and atopic dermatitis.

Jefferies said that its estimates peak sales of $3.5 billion for the med across all indications, although it adds this “may be too conservative” given the issues for Lilly/Incyte, coupled with “these promising initial results.”

Both Jefferies and Barclays says that they believe, with the usual cross-comparison caveats, that it could edge out Olumiant on efficacy.

Jefferies was also bullish on AbbVie’s R&D prospects in general: “AbbVie has one of the best R&D pipelines in the industry, in our view, with multiple blockbuster potential read outs in 2017. Key catalysts include: 1) Next-gen HCV PDUFA mid'17; 2) Venclexta MURANO read out mid'17; 3) Rova-T TRINITY read out H2'17; 4) Further ABT-494 PIII read outs in RA through 2017; 5) Risankizumab PIII read outs in psoriasis H2'17; 6) Imbruvica PIII interim looks in 1L DLBCL & r/r FL H2'17/ Q1'18."

“Elagolix PIII read out in uterine fibroids in late 2017, as well as full SOLSTICE data in endometriosis. We believe that a protracted legal timeline for US Humira biosimilars combined with pivotal data from the pipeline should at least stabilize AbbVie’s current multiple against its strong earnings growth as these become more visible over the next 12 months.”

AbbVie, with a market cap of around $110 billion and looking for a future without Humira, was up 1.6% on the news this morning.

Editor's note: This story was updated to show that Pfizer's Xeljanz is an oral drug, not an injectable as previously implied.