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ABBV Gets CHMP Nod for Rinvoq in Two Different Autoimmune Diseases
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Key Takeaways
AbbVie received positive CHMP opinions for Rinvoq in severe alopecia areata and non-segmental vitiligo.
ABBV expects European Commission decisions in the coming months for both Rinvoq indications under review.
AbbVie also secured FDA approval for Skyrizi in pediatric plaque psoriasis or psoriatic arthritis.
AbbVie (ABBV - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for its blockbuster immunology drug, Rinvoq (upadacitinib), for the treatment of adolescent and adult patients with severe alopecia areata (AA).
Separately, the CHMP also rendered a positive opinion recommending approval of Rinvoq for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV).
A final decision from the European Commission is expected in the coming months for both indications. If approved for the NSV indication, Rinvoq is likely to become the first systemic medication approved for this patient population.
Rinvoq is presently approved for several indications in the EU, including atopic dermatitis, radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis.
Regulatory applications seeking approval of Rinvoq in NSV and AA are also under review in the United States.
ABBV’s Price Performance
Year to date, shares of AbbVie have risen 12.7% compared with the industry’s growth of 13.1%.
Image Source: Zacks Investment Research
ABBV Gets FDA Nod for Skyrizi in Psoriatic Disease
In a separate press release, AbbVie announced that the FDA has approved its other blockbuster immunology drug, Skyrizi (risankizumab), for the treatment of children aged six years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or with active psoriatic arthritis.
The latest FDA approval includes a new 55 mg pre-filled syringe (PFS) for patients weighing less than 40 kg, while the existing 150 mg PFS and Pen remain approved for patients weighing 40 kg or more.
Following the nod, Skyrizi became the first and only IL-23 inhibitor to be approved for treating pediatric patients aged six years and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis in the United States.
The approval was based on data from the phase III OptIMMize psoriasis clinical program.
Last week, Skyrizi was approved in the EU for children and adolescents aged six years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Skyrizi is currently approved for the treatment of adult patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, both in the United States and in Europe.
ABBV Bets on Skyrizi & Rinvoq to Aid Revenues
Both Skyrizi and Rinvoq continue to deliver strong growth across their approved indications. These medicines have played a key role in offsetting the continued decline in sales of AbbVie's legacy drug Humira, which has faced biosimilar competition in the United States since 2023.
In the first quarter of 2026, Skyrizi sales increased 29.2% year over year to $4.48 billion, while Rinvoq sales rose 20.2% to $2.12 billion. Together, the two medicines were key contributors to AbbVie's double-digit revenue growth during the quarter.
Reflecting their continued momentum, the company raised its 2026 sales guidance for both drugs by $100 million each and now expects Skyrizi and Rinvoq to generate $21.6 billion and $10.2 billion in sales, respectively, this year. Combined, the two medicines are projected to deliver more than 20% sales growth in 2026.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have surged 43.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 126.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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ABBV Gets CHMP Nod for Rinvoq in Two Different Autoimmune Diseases
Key Takeaways
AbbVie (ABBV - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for its blockbuster immunology drug, Rinvoq (upadacitinib), for the treatment of adolescent and adult patients with severe alopecia areata (AA).
Separately, the CHMP also rendered a positive opinion recommending approval of Rinvoq for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV).
A final decision from the European Commission is expected in the coming months for both indications. If approved for the NSV indication, Rinvoq is likely to become the first systemic medication approved for this patient population.
Rinvoq is presently approved for several indications in the EU, including atopic dermatitis, radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis.
Regulatory applications seeking approval of Rinvoq in NSV and AA are also under review in the United States.
ABBV’s Price Performance
Year to date, shares of AbbVie have risen 12.7% compared with the industry’s growth of 13.1%.
Image Source: Zacks Investment Research
ABBV Gets FDA Nod for Skyrizi in Psoriatic Disease
In a separate press release, AbbVie announced that the FDA has approved its other blockbuster immunology drug, Skyrizi (risankizumab), for the treatment of children aged six years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or with active psoriatic arthritis.
The latest FDA approval includes a new 55 mg pre-filled syringe (PFS) for patients weighing less than 40 kg, while the existing 150 mg PFS and Pen remain approved for patients weighing 40 kg or more.
Following the nod, Skyrizi became the first and only IL-23 inhibitor to be approved for treating pediatric patients aged six years and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis in the United States.
The approval was based on data from the phase III OptIMMize psoriasis clinical program.
Last week, Skyrizi was approved in the EU for children and adolescents aged six years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Skyrizi is currently approved for the treatment of adult patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, both in the United States and in Europe.
ABBV Bets on Skyrizi & Rinvoq to Aid Revenues
Both Skyrizi and Rinvoq continue to deliver strong growth across their approved indications. These medicines have played a key role in offsetting the continued decline in sales of AbbVie's legacy drug Humira, which has faced biosimilar competition in the United States since 2023.
In the first quarter of 2026, Skyrizi sales increased 29.2% year over year to $4.48 billion, while Rinvoq sales rose 20.2% to $2.12 billion. Together, the two medicines were key contributors to AbbVie's double-digit revenue growth during the quarter.
Reflecting their continued momentum, the company raised its 2026 sales guidance for both drugs by $100 million each and now expects Skyrizi and Rinvoq to generate $21.6 billion and $10.2 billion in sales, respectively, this year. Combined, the two medicines are projected to deliver more than 20% sales growth in 2026.
ABBV’s Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) , Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have surged 43.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 126.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.