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AbbVie (ABBV) Seeks Approval for Skyrizi for Ulcerative Colitis

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AbbVie (ABBV - Free Report) announced the submission of regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of its drug Skyrizi (risankizumab) for a new indication, moderately to severely active ulcerative colitis.

Skyrizi, an interleukin-23 (IL-23) inhibitor, is presently approved in the United States and Europe for Crohn's disease, psoriatic arthritis and psoriasis.

The regulatory applications filed to the FDA and the EMA are based on data from two phase III studies, an induction study, INSPIRE, and a maintenance study, COMMAND. In these studies, a higher number of patients treated with risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) compared to placebo. In addition, in both studies, more risankizumab-treated patients achieved the key secondary endpoints of endoscopic improvement and histologic endoscopic mucosal improvement compared to placebo.

Year to date, AbbVie’s shares have lost 8.8% against the industry’s 7.6% rise.

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Skyrizi recorded sales of $2.77 billion in the first half of 2023, up 49% year over year, on an operational basis. Skyrizi and AbbVie’s other newer inflammatory drug, Rinvoq are performing extremely well, bolstered by approvals in new indications. Both have the potential to drive the top line to make up for lost Humira revenues.

AbbVie’s key blockbuster immunology medicine, Humira lost patent protection in the United States in 2023.InJanuary, Amgen (AMGN - Free Report) launched the first Humira biosimilar in the United States called Amjevita. After Amgen, several other companies like Boehringer Ingelheim, Coherus BioSciences and Novartis (NVS - Free Report) also launched their own Humira biosimilars. Novartis, through its generic division, Sandoz, markets its Humira biosimilar under the trade name Hyrimoz. Humira biosimilars were launched in the EU in October 2018, which have been eroding international sales from the branded drug since 2019.

Skyrizi and Rinvoq recorded $4.85 billion in AbbVie’s combined sales in the first half of 2023.

AbbVie launched Skyrizi and Rinvoq across Humira's major indications, plus a distinct new indication, atopic dermatitis. With approvals for many new indications, sales of these drugs could be higher in future quarters, which should support top-line growth in the next few years. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. AbbVie expects combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $17.5 billion by 2025 and more than $21 billion by 2027.

AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim. AbbVie leads the global development and commercialization of Skyrizi.

Zacks Rank

AbbVie currently has a Zacks Rank #3 (Hold).

AbbVie Inc. Price and Consensus

AbbVie Inc. Price and Consensus

AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote

A better-ranked large drug stock worth considering is J&J (JNJ - Free Report) , which has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for J&J’s 2023 earnings per share have increased from $10.66 to $10.75 over the past 60 days. Estimates for 2024 have jumped from $11.01 per share to $11.30 in the same timeframe. J&J’s stock has declined 7% year to date.

J&J beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.58%, on average.

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