Another day, another delay: FDA pushes back a second review for AbbVie's Rinvoq, this time in atopic dermatitis
AbbVie is continuing to look for ways to expand its Rinvoq franchise, betting the drug can be the next big thing once Humira’s patent runs out in a couple years. But on Friday the pharma ran into its second stumbling block at the FDA in the last few weeks.
Regulators have extended the review period for Rinvoq, also known as upadacitinib, in moderate to severe atopic dermatitis by three months until early in the third quarter, AbbVie announced Friday, citing the agency’s request for an updated benefit-risk profile. The delay follows a separate extension for the drug in psoriatic arthritis in mid-March.
AbbVie had disclosed the agency’s AD request at the time of the previous delay, in which the FDA also asked for an updated benefit-risk profile in psoriatic arthritis. Regulators on Friday formally made the decision to push back the PDUFA date in AD.
“We are confident in the sNDA and continue to work with the FDA to bring upadacitinib to patients,” AbbVie president R&D Michael Severino said in a statement.
The news marks another red flag in safety for JAK inhibitors, a field in which several drugs already come with black box warnings like Pfizer’s Xeljanz and Eli Lilly’s Olumiant. When it was first approved in 2019 for rheumatoid arthritis, Rinvoq carried a similar label, noting heightened risk for serious infections, malignancy and thrombosis.
AbbVie faces headwinds in atopic dermatitis specifically, with Regeneron and Sanofi’s IL-4 and IL-13 drug Dupixent dominating the market since approval. Rinvoq’s mere reputation as a JAK could limit the drug’s uptake and prevent it from ever meaningfully challenging Dupixent in the first-line setting.
Regardless, AbbVie has been making a push for two of its newer drugs — Rinvoq and the IL-23 drug Skyrizi — as potential heirs to the Humira throne. In addition to AD and psoriatic arthritis, AbbVie is evaluating the drugs in multiple IBD indications like Crohn’s disease and ulcerative colitis, a field which SVB Leerink analyst Geoffrey Porges thinks could prove extremely promising.
That market could be worth as much as $32 billion by 2025, Porges projects, and he denotes AbbVie as a potential beneficiary of the upcoming boom should its two drugs both enter the market by next year. Despite the JAK safety issues, Porges found a higher uptake of the drugs in IBD than previously expected, leading to a potential one-two punch of Rinvoq and Skyrizi as new revenue drivers.
Now, though, AbbVie remains in a holding pattern for Rinvoq as the FDA continues to review the two supplemental NDAs. When the psoriatic arthritis delay was announced last month, AbbVie $ABBV shares dropped roughly 6% but have since nearly recovered in the following weeks.