AbbVie ABBV announced the FDA approval of its immunology drug, Rinvoq (upadacitinib), a once-daily pill for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or moretumor necrosis factor blockers. Rinvoq is one of AbbVie’s newer drugs. This approval by the FDA marks the seventh FDA-approved indication for Rinvoq across rheumatology, dermatology and gastroenterology.
Rinvoq is already approved for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy and ulcerative colitis in certain patients in several countries.
In the past year, shares of AbbVie have lost 5% against the industry’s 9.4% rise.
Image Source: Zacks Investment Research
The FDA approval was based on positive data from two induction studies, U-EXCEED and U-EXCEL and one maintenance study, U-ENDURE. The company achieved both co-primary endpoints of endoscopic response and clinical remission, as well as key secondary endpoints of rapid clinical response and corticosteroid-free clinical remission, with statistical significance. In the induction studies, 45 mg dose of Rinvoq was used and dose strengths of 15 mg and 30 mg of Rinvoq were used in the maintenance study, compared with placebo.
The endoscopic response was observed in 34% and 46% of patients treated with a 45 mg dose of Rinvoq, in the two induction studies at week 12, respectively, compared with 3% and 13% of patients receiving placebo. In the maintenance study, 28% and 41% of patients treated with 15 mg and 30 mg doses of Rinvoq, respectively, achieved endoscopic response at week 52.
A clinical remission was achieved in 36% and 46% of patients treated with Rinvoq 45 mg, in the two induction studies at 12 weeks, respectively, compared with 18% and 23% of patients receiving placebo. Moreover, 42% and 55% of patients treated with Rinvoq 15 mg and 30 mg achieved clinical remission at 52 weeks in the maintenance study, compared with 14% of patients receiving placebo.
Crohn’s disease is a chronic and progressive disease that causes inflammation in the digestive tract. The symptoms of this disease include persistent diarrhea and abdominal pain. Due to the unpredictable nature of its symptoms, Crohn’s disease severely hampers the quality of life of patients living with this disease.
Per management, the study outcomes show that treatment with Rinvoq results in both early and long-term symptom relief in Crohn’s disease, along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation.
Several phase III label-expanding studies of Rinvoq are currently ongoing in several indications, comprising rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis.
AbbVie Inc. Price and Consensus
AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote
Zacks Rank and Stocks to Consider
AbbVie currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the overall medical sector include Novo Nordisk NVO, Novartis NVS and Allogene Therapeutics ALLO. While Novo Nordisk currently sports a Zacks Rank #1 (Strong Buy), Novartis and Allogene, both have a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the Zacks Consensus Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.43 to $4.95. Shares of Novo Nordisk have gained 56.4% in the past year.
NVO beat estimates in three of the last four quarters and missed the mark on one occasion, delivering an earnings surprise of 0.35%, on average.
In the past 60 days, the Zacks Consensus Estimates for Novartis’ 2023 earnings per share have increased from $6.55 to $6.67. Shares of NVS have rallied 12.2% in the past year.
NVS beat estimates in each of the last trailing four quarters, delivering an earnings surprise of 5.15%, on average.
In the past 60 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.50 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 18.7%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report