AbbVie Inc. ABBV announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and recommended granting approval to its JAK inhibitor drug — Rinvoq (upadacitinib) — for yet another new indication.
The committee recommended approval of once-daily Rinvoq (15 mg) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging, having responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
The CHMP’s opinion will now be reviewed by the European Commission ("EC"), with decision from the same expected in the third quarter of 2022.
The latest positive CHMP opinion for Rinvoq was based on data from the phase III SELECT-AXIS 2 study, which met the primary endpoint of ASAS40 response versus placebo at week 14.
Axial spondyloarthritis is a chronic inflammatory disease that affects the spine and consists of two sub-groups — ankylosing spondylitis (“AS”) and nr-axSpA. Rinvoq is already approved in Europe for the AS indication.
Shares of AbbVie have rallied 12.5% so far this year compared with industry’s increase of 5.9%.
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Other than the AS indication, Rinvoq is also approved in the EU for several indications — rheumatoid arthritis, active psoriatic arthritis (PsA) and atopic dermatitis. Last month, the CHMP recommended approval of Rinvoq for the treatment of adult patients with moderately to severely active ulcerative colitis (“UC”). A decision from the EC is also expected in the third quarter of 2022.
A potential approval for the UC and nr-axSpA indication will expand the therapeutic indication for Rinvoq in the EU, thereby enabling the drug to treat a broader patient population and drive sales higher in the days ahead.
Rinvoq is currently under review in the United States for treating adult patients with active nr-axSpA. The FDA approved Rinvoq for treating adults with active AS in April 2022.
Rinvoq, along with another blockbuster drug, Skyrizi, remains critical for ABBV to gradually lower its dependence on blockbuster medicine, Humira. Sales of Humira are declining due to biosimilars eroding its yearly international sales. Biosimilars of Humira are expected to be launched in the United States in 2023.
AbbVie expects combined sales of Skyrizi and Rinvoq to be more than $15 billion by 2025.
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the healthcare sector are United Therapeutics Corporation UTHR, Novo Nordisk A/S NVO and Precision BioSciences, Inc. DTIL. While UTHR sports a Zacks Rank #1 (Strong Buy), NVO and DTIL both hold a Zacks Rank #2 (Buy) presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for United Therapeutics’ earnings has been revised 22.4% upward for 2022 and 14% upward for 2023. The stock has rallied 10.6% year to date.
Earnings of United Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. UTHR delivered an earnings surprise of 15.34%, on average.
Novo Nordisk’s earnings have been revised 3.9% upward for 2022 and 6.3% upward for 2023. The stock has inched up 0.1% year to date.
Earnings of Novo Nordisk have surpassed estimates in each of the trailing four quarters. NVO delivered an earnings surprise of 7.56%, on average.
Precision BioSciences’ loss per share estimates narrowed 26.2% for 2022 and 42.5% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
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