AbbVie's big Rinvoq ambitions—and the larger JAK class—face even more uncertainty with latest FDA delays

AbbVie
The FDA has delayed its decision for AbbVie's Rinvoq in psoriatic arthritis and ankylosing spondylitis as the agency's safety review for Pfizer's Xeljanz drags on. (AbbVie)

AbbVie’s big expansion for Rinvoq is still unable to move forward, thanks to FDA delays that spell trouble across the entire JAK inhibitor class. But at least one analyst isn’t sounding the alarm yet.

The FDA won’t be able to reach decisions for Rinvoq’s applications in psoriatic arthritis and ankylosing spondylitis in June as promised, AbbVie said Friday.

The company didn’t say whether the agency has provided a new decision date. For the psoriatic arthritis indication, the news marks the second deferral.

The problem arises from the FDA’s safety concerns after Pfizer’s fellow JAK inhibitor Xeljanz turned up additional risks for dangerous heart side effects and cancer in a post-marketing study in patients with rheumatoid arthritis.

RELATED: FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags

In postponing Rinvoq, the FDA said it’s still reviewing those Pfizer data, according to AbbVie. In February, the agency alerted patients and doctors of Xeljanz’s safety signal. At that time, it said it would dig into the results and consider what moves to take.

Existing JAK inhibitors, including Rinvoq, already bear warnings of increased risk of blood clots on their U.S. labels. Xeljanz’s cardiovascular red flag obviously made the FDA nervous about it being a class-wide problem for all JAK drugs.

Still, as Piper Sandler analyst Christopher Raymond observed in a Friday note, it’s unlikely that Rinvoq “would be painted with the same brush as Xeljanz,” given the AbbVie drug selectively targets JAK1 and has shown a clean cardiovascular and cancer safety profile with rates of about 0.4 and 0.8 events per 100 patient-years, respectively. But Raymond also acknowledged that the new delays and the FDA’s stated concern that got passed on from Xeljanz “clearly cast more doubt on Rinvoq’s label expansion hopes.”

RELATED: AbbVie's big Rinvoq ambitions hit an FDA snag as JAK safety questions persist

The changed regulatory timeline does put into question AbbVie’s target of hitting $8 billion sales for Rinvoq in 2025. But Raymond said he’s not “hitting the panic button” just yet. He also pointed to the positive opinion from the European Medicines Agency’s drug reviewers on approving Rinvoq in atopic dermatitis as a good sign that the drug will eventually pass muster at the FDA.

The FDA has so far delayed multiple decisions for the drug class. Besides psoriatic arthritis and ankylosing spondylitis, it has also pushed back a verdict for Rinvoq in atopic dermatitis to July. AbbVie didn’t immediately respond to a request for clarification on the fate of that application.

Other drugs that have suffered similar fate include Xeljanz in ankylosing spondylitis, Eli Lilly’s Olumiant and Pfizer’s investigational abrocitinib in atopic dermatitis as well as Incyte’s Jakafi in chronic graft-versus-host disease and ruxolitinib cream for eczema.

AbbVie has a lot hanging on Rinvoq, which, alongside Skyrizi, is tasked with steadying the ship when megablockbuster immunology drug Humira loses U.S. patent protection in 2023.