Even AbbVie CEO can't confirm Rinvoq's sales as FDA mulls JAK label

AbbVie
As the final FDA label for Rinvoq remains forthcoming, AbbVie CEO Rick Gonzalez declined to reconfirm the company's $8 billion 2025 sales projection for the JAK inhibitor. (AbbVie)

When the FDA dropped the bombshell that it would add more safety warnings and restrict the use of JAK inhibitors, industry watchers began weighing the impact on a key player: AbbVie’s Rinvoq. But right now, even AbbVie’s CEO isn’t sure how much damage the update will do.

As the final FDA label for Rinvoq remains forthcoming, “we don’t want to reconfirm the guidance yet,” AbbVie CEO Rick Gonzalez said during an investors’ call Friday. AbbVie had Rinvoq’s risk-adjusted 2025 sales at $8 billion as of December 2020.

Rinvoq, alongside IL-23 inhibitor Skyrizi, is a key component in AbbVie’s plan to replace immunology king Humira when the TNF blocker loses U.S. exclusivity in 2023. But the unexpected classwide FDA restrictions on oral JAK agents are raising some doubts about Rinvoq’s future.

Although the AbbVie helmsman wouldn’t give a definite answer on the therapy's sales potential now, he did express confidence in the two up-and-coming immunology stars.

RELATED: FDA's new JAK safety restrictions spell trouble for AbbVie's Rinvoq, but to what extent?

“Everything I know about these two assets, they’ll be able to do exactly what we expect of them even in the most negative outcome from a label standpoint,” Gonzalez said.

Rinvoq’s current label covers rheumatoid arthritis, and it’s awaiting FDA decisions on atopic dermatitis, psoriatic arthritis and ankylosing spondylitis. AbbVie has also recently filed Rinvoq for ulcerative colitis. There, the drug’s clinical data have outperformed what AbbVie had originally expected in drafting up the 2025 sales guidance and could therefore be “a very significant opportunity,” Gonzalez said.  

After a postmarketing study of Pfizer’s JAK drug Xeljanz turned up an increased risk of heart-related side effects and cancer, the FDA said in September that it would update the black-boxed warning for all three oral JAK drugs and push their use behind TNF blockers. Rinvoq was one of the three meds hit.

AbbVie is still talking with the FDA about the specific language of the new label, the company's president, Mike Severino, said on the call. And as that discussion remains ongoing, FDA decisions on the three upcoming indications are being delayed, he added.

RELATED: AbbVie touts more Rinvoq data in inflammatory spinal arthritis as it awaits key FDA decisions

Limiting Rinvoq’s use to the post-TNF setting would hurt Rinvoq in the near term, Gonzalez acknowledged, especially given the drug has been capturing some front-line patients. A shift to the second line was actually in AbbVie’s plan, the chief executive said, only that has now arrived earlier.

In the meantime, Rinvoq's market performance doesn't seem to have been affected. Sales in the third quarter hit $453 million, representing nearly 20% growth over the second quarter. The drug has taken 17% of the U.S. rheumatoid arthritis new and switching share, Jeff Stewart, AbbVie’s commercial chief, said on the call.

The situation matches what Evercore ISI analyst Josh Schimmer got from interviewing a rheumatologist with a large practice in Mississippi a month ago. At that time, the doctor said he was still prescribing Rinvoq as usual, including in some frontline patients, although he had significantly cut back the use of Xeljanz after the postmarketing readout in January. However, he expects payers will make Rinvoq access a lot harder, especially in the first line, after the official label update.

As for Skyrizi, sales jumped 18% sequentially to $796 million in the third quarter. In the U.S. psoriasis market, Skyrizi is leading all biologics with 36% share among new and switching patients, Stewart said.

Humira also turned in a decent quarter, with sales up 5.2% to $5.4 billion in the third quarter. Overall, AbbVie’s total haul during the three months reached $14.34 billion, up 10.8% operationally.