AbbVie Pins Hopes on Rinvoq to Drive Next Phase of Growth

AbbVie ABBV holds a dominant position in the immunology market, which is being aided by strong sales of its two new immunology medicines, Rinvoq and Skyrizi. The drugs have not only mitigated the impact of Humira’s continued sales erosion but also reaffirmed their role as growth drivers for AbbVie.

AbbVie lost patent protection for its blockbuster drug, Humira, in the United States in January 2023. Humira's sales are declining due to loss of exclusivity and biosimilar erosion.

Rinvoq has been witnessing strong sales performance across all its approved indications, especially in the popular inflammatory bowel disease space, which includes two conditions, ulcerative colitis and Crohn’s disease. The potential approval of Rinvoq for five new indications over the next few years is expected to boost the drug’s sales and drive ABBV’s future growth.

Earlier this week, AbbVie announced positive top-line data from the second study, Study 1, of its pivotal phase III UP-AA clinical program on Rinvoq for the treatment of severe alopecia areata. The study achieved the primary endpoint. At 24 weeks, 45.2% of patients on the 15 mg dose and 55% on the 30 mg dose achieved 80% or more scalp hair coverage, compared to 1.5% with placebo. The study also met key secondary endpoints, including improvements in eyebrow and eyelash growth and complete scalp hair regrowth. The findings from this study were consistent with those reported from the first pivotal study, Study 2, of the UP-AA program on Rinvoq. The safety profile was also consistent with previous studies, with no new safety concerns identified.

AbbVie expects to file a regulatory submission for Rinvoq for the alopecia areata indication later in 2025. In addition, phase III data with Rinvoq in vitiligo are expected later in 2025, followed by readouts from phase III studies on hidradenitis suppurativa and systemic lupus erythematosus in 2026.

In the first half of 2025, Rinvoq generated sales of $3.7 billion, reflecting a 49% year-over-year increase. Rinvoq sales remain on track to be around $8 billion for 2025. AbbVie believes that the next wave of potential approvals for Rinvoq, like alopecia areata, could add roughly $2 billion to peak-year sales for the product.

ABBV’s Potential Competition in the Target Market

The targeted market remains highly competitive. Upon potential approval for alopecia areata, Rinvoq is likely to face acute competition from other established players in the target market.

Eli Lilly LLY and Incyte’s INCY Olumiant (baricitinib) is approved for treating moderately to severely active rheumatoid arthritis and severe alopecia areata. Lilly and Incyte’s Olumiant generated sales of $475.2 million in the first half of 2025.

Drug giant Pfizer’s PFE Litfulo (ritlecitinib) was approved by the FDA in 2023 for the treatment of alopecia areata in individuals aged 12 years and older. Pfizer is currently developing Litfulo in a late-stage study for an additional indication – Vitiligo.

Several other companies currently market or are developing treatments for alopecia areata, which, upon potential approval, is likely to make the target market even more competitive.

ABBV’s Price Performance, Valuation and Estimates

Shares of AbbVie have rallied 17.9% year to date against the industry’s decline of 1.6%.

From a valuation standpoint, AbbVie is trading at a premium to the industry. Based on the price/earnings (P/E) ratio, the company’s shares currently trade at 15.54 times forward earnings, higher than its industry’s average of 14.64. The stock is also trading above its five-year mean of 12.69.

The Zacks Consensus Estimate for 2025 earnings has declined from $12.03 per share to $12.02, while that for 2026 has increased from $14.08 to $14.31 per share over the past 30 days.

ABBV’s Zacks Rank

AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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