AbbVie's Rinvoq rollout on track despite JAK safety concerns, but uncertainty remains: analyst

Just a few months ago, AbbVie's Rinvoq was riding high—and racing toward two new indications to boot. But after in-class rival Xeljanz put up some unflattering heart safety data, the FDA tapped the brakes on both those potential approvals, delaying decisions until later this year.

Not to worry, one analyst says. After surveying nearly two dozen rheumatologists, Evercore ISI's Josh Schimmer figures Rinvoq's still headed toward blockbusterland.

While there’s “significant uncertainty” for Rinvoq in the long run, doctors "still see growth for the JAK class,” Schimmer wrote to clients in a note Wednesday. At this point, rheumatologists are “changing prescribing patterns in higher-risk patients, but not much beyond that," Schimmer wrote.

The analyst and his team surveyed doctors months after Pfizer’s JAK inhibitor Xeljanz failed an FDA-required post-marketing safety study. The study compared Xeljanz to a TNF inhibitor in more than 4,300 patients over age 50 who had rheumatoid arthritis and at least one cardiovascular risk factor.  

Investigators found 98 cases of cardiovascular events among Xeljanz patients versus 37 in the TNF inhibitor group, according to data unveiled in late January, and 122 patients taking Xeljanz developed cancers, compared with 42 on TNF inhibitors. 

RELATED: Pfizer's Xeljanz fails RA safety study, making a tough rivalry with AbbVie's Rinvoq even tougher 

After that study, the FDA postponed its decision on AbbVie’s Rinvoq in psoriatic arthritis. The company didn’t disclose a reason for the delay, but analysts believed it stemmed from the Xeljanz study results.

Then, this month, the FDA pushed back its decision deadline on Rinvoq in atopic dermatitis and delayed decisions on JAK meds from Eli Lilly and Pfizer in the same indication, offering even more evidence that the agency is taking a close look at the drug class. 

Schimmer and his team posed questions to 23 rheumatologists nationwide and found that the doctors are “slightly more negative on the JAK class,” but that there’s “confusion about how to extrapolate” the safety concerns beyond Xejlanz. 

The surveyed docs together treat 434 patients with AbbVie’s Rinvoq, a number they expect to grow by 110% over the next year and by 160% over the next three to five years. Based on the drug’s fourth-quarter sales of $281 million, that would indicate Rinvoq is on track to grow to $2.1 billion in U.S. sales next year, Schimmer wrote. 

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

Further, the drug is on track to grow to around $4 billion in worldwide sales in rheumatoid arthritis and psoriatic arthritis in 2025, Schimmer wrote. That would come in slightly below AbbVie’s own expectations of $4.75 billion to $5 billion in those uses, he noted. Still, Schimmer wrote that there’s a potential upside to his 2022 estimate based on other indications such as atopic dermatitis and ulcerative colitis. 

For AbbVie, a successful Rinvoq launch is paramount. The company is gearing up for a massive Humira loss of exclusivity in 2023 and has said its new immunology duo—Rinvoq and Skyrizi—can grow to $15 billion in worldwide sales by 2025. Humira was the world’s bestselling drug again in 2019, generating $19.8 billion. Multiple biosimilars are set to eat away at its U.S. sales starting in 2023.  

After the FDA held up Rinvoq’s application in psoriatic arthritis, AbbVie’s shares fell by around 6%, demonstrating just how closely investors are watching the drug launch.