AbbVie chases its next golden goose in a post-Humira future with new ulcerative colitis data for Rinvoq
Still bathing in the afterglow of its big-money acquisition of Allergan, AbbVie faces the dark cloud of a post-Humira future — and the deadline is approaching fast. Key to AbbVie’s plan are two immunology launches with aggressive clinical dreams; one of those, JAK inhibitor Rinvoq, is now one step closer to another Humira-matching approval.
AbbVie’s Rinvoq (upadacitinib) bested placebo in helping ulcerative colitis patients achieve clinical remission at the eight-week mark and significantly reduced key symptomatic biomarkers, including gastrointestinal inflammation, according to data from the Phase III U-Achieve study unveiled Wednesday.
Twenty-six percent of patients dosed with a once-daily, 45-mg dose of Rinvoq hit clinical remission after two months compared with just 5% on placebo, AbbVie said. Rinvoq also induced gastrointestinal improvement in 36% of patients; meanwhile, just 7% patients on placebo hit that mark.
Rinvoq also aced its other secondary endpoints over placebo, including achieving clinical response in patients and reducing swelling of the mucosal lining. U-Achieve is one of two inductive studies AbbVie has planned for Rinvoq in UC along with three pivotal trials for a possible regulatory submission.
Rinvoq’s UC quest is part of a wide-ranging clinical program for the drug that includes ongoing late-stage trials for unapproved indications in atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis and Takayasu’s arteritis.
The end goal is simple and driven by a looming axe in AbbVie’s portfolio: Rinvoq must eventually snare enough indications to make up for the sales loss of megablockbuster Humira, which is facing US biosimilar competition starting in 2023.
That timeline would give Rinvoq, which originally notched an FDA approval to treat moderate-to-severe rheumatoid arthritis back in August 2019, roughly three years to gain enough momentum to begin offsetting Humira’s expected decline. But it won’t be a sure-fire path to success: Rinvoq sports a JAK class warning label for serious infections, malignancy and thrombosis that has spooked many rheumatologists off the drugs and could make a major market entry into any of those new indications a difficult road.
Luckily, AbbVie isn’t putting all its eggs into one basket as it looks into the post-Humira future. The Chicago drugmaker also sports recent psoriasis launch Skyrizi, which it hopes to pair up with Rinvoq as a one-two punch to match Humira highest sales peak. AbbVie is so gung-ho about the pair’s chances that CEO Rick Gonzalez posited in January at the JP Morgan Healthcare Conference that the two drugs could hit a combined $20 billion in annual sales if they snag all of Humira’s approvals and add more — atopic dermatitis, for instance.
Meanwhile, AbbVie is still in the process of digesting its $63 billion acquisition of Allergan, which brought aesthetic/therapeutic blockbuster Botox into the fold. Allergan came in sporting booming antipsychotic Vraylar as well, tacking a second growth driver onto the new company’s lapel.