The wait is over: AbbVie's Rinvoq chalks up FDA win with favorable atopic dermatitis label

AbbVie can breathe a sigh of relief: Rinvoq, the Illinois pharma’s Humira successor, has emerged from an FDA safety probe with a relatively favorable label in the all-important atopic dermatitis indication.

The FDA has cleared Rinvoq for treating patients with moderate to severe atopic dermatitis who have failed—or aren’t suitable for—other pills or injections, AbbVie said Friday. Notably, both the 15-mg and 30-mg daily strengths scored FDA backings.

The approval for the 30-mg dose marks a win for AbbVie because the FDA has recently put a safety spotlight on JAK inhibitors such as Rinvoq in inflammatory diseases out of concerns over their heart safety and cancer risks. With the higher dose approved, the more efficacious version of the drug will be available to doctors and patients.

After the FDA in December pushed back Rinvoq’s use in its existing rheumatoid arthritis use behind old-school TNF inhibitors such as Humira, industry watchers lowered their sales estimates for the drug. For its part, AbbVie last week dialed back its Rinvoq sales projection by $500 million to $7.5 billion in 2025, with $1.7 billion of that total expected to come from atopic dermatitis. On Tuesday, a company spokesperson said that guidance "remains intact."

RELATED: AbbVie's Rinvoq, Pfizer's Xeljanz and Lilly's Olumiant slapped with new FDA warnings amid JAK safety crackdown

At the 15-mg dose, Rinvoq might be just another eczema drug. But the 30-mg dose could differentiate it from other meds. The higher dose topped Sanofi and Regeneron’s blockbuster Dupixent at helping more eczema patients achieve skin clearance. 

Although the FDA label doesn’t yet include that phase 3b data, the approval of the 30-mg dose opens the door for doctors to treat patients with a more efficacious version of Rinvoq—but not before they’ve tried Dupixent and other meds. The high dose is also restricted to patients younger than 65 years of age on top of the indication-wide limitation to patients who’re refractory to other systemic therapies.

The AbbVie spokesperson didn’t respond to a question about whether the FDA had reviewed the Dupixent head-to-head data.

Despite the label limitations, Wall Street analysts and AbbVie have indicated that post-Dupixent use has always been the place they had in mind for Rinvoq in eczema. But FDA’s language suggests Rinvoq may get behind future drugs, too.

For now, a recent survey by Spherix indicated that dermatologists increasingly view Rinvoq as differentiated over other oral JAKs, with over a third planning to use the AbbVie drug in eczema within three months of approval, Piper Sandler’s Christopher Raymond said in a Friday note.

RELATED: After delays, Pfizer's blockbuster-to-be eczema drug Cibinqo snags FDA nod

The safety scrutiny for the drug class came after an FDA-required postmarketing study of Pfizer’s Xeljanz linked the JAK inhibitor with increased heart disease and cancer risks over TNF blockers in a group of older rheumatoid arthritis patients with underlying cardiovascular risk factors.

Despite the risks being linked to only Xeljanz, the FDA saw it as a classwide problem. Rinvoq, Pfizer’s follow-on JAK med Cibinqo, Eli Lilly’s Olumiant and even Incyte’s Opzelura cream now all carry similar boxed warnings about major cardiovascular events, blood clots, cancer and death related to JAK inhibitors.

After a safety update in December, the FDA has waved through Rinvoq in psoriatic arthritis and Xeljanz in ankylosing spondylitis with post-TNF restrictions. Also on Friday, Cibinqo got its eczema nod with a label similar to that of Rinvoq’s in the indication.

For Rinvoq’s entire market potential across the multiple indications AbbVie is targeting, industry watchers are less optimistic than AbbVie. The Wall Street consensus for 2025 sales is $5.5 billion, compared with AbbVie’s $7.5 billion, according to Evercore ISI.