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AbbVie (ABBV) Down as FDA Extends Review of Rinvoq sNDA
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AbbVie (ABBV - Free Report) announced that the FDA has extended the review period fora supplemental new drug application (sNDA) for its JAK-inhibitor drug, Rinvoq (upadacitinib), by three months. The sNDA is seeking label expansion of Rinvoq to treat patients with active psoriatic arthritis. A decision from the FDA is now expected by the end of the second quarter.
Shares of AbbVie declined 5.2% on Mar 17 following the announcement. In fact, the company’s shares have decreased 1.9% so far this year against the industry’s 0.5% growth.
Why the Extension
Recently, the FDA has requested the company to provide updated data on the benefit-risk profile of Rinvoq in psoriatic arthritis. The company submitted the requested data, following which the regulatory authority decided to extend the review period for the sNDA for the full review of the data.
Some analysts are wondering whether the requirement for additional safety data on Rinvoq is related to concerns about JAK inhibitors. Recently, the FDA issued a statement that Pfizer’s (PFE - Free Report) JAK inhibitor, Xeljanz, may increase the risk of heart-related problems and cancer. The statement was based on data from a study that compared the drug to another class of drugs — tumor necrosis factor (TNF) inhibitors. Analysts believe that the extension in the Rinvoq sNDA review period might be due to the spill-over effect of the Xeljanz study, as boththe drugs are JAK inhibitors.
We note that Rinvoq is already approved as an oral, once-daily treatment for rheumatoid arthritis (RA) in the United States and Europe. The drug is also approved for treating psoriatic arthritis and ankylosing spondylitis in Europe. However, the drug’s label includes warnings about serious infections, including blood clots and cancer. A FDA decision to include strict warnings for serious health hazards in the anticipated label for psoriatic arthritis is likely to hamper the drug’s prospects.
Moreover, another sNDA seeking the label expansion for Rinvoq to treat adult patients (15 mg and 30 mg) and adolescents (15 mg) with moderate-to-severe atopic dermatitis or eczema is under review. The FDA has requested to provide similar updated data on the benefit-risk profile of Rinvoq in this patient populations as well. AbbVie is preparing the requested data and will submit them to the FDA shortly. This submission may also lead to the extension of the review period for the eczema sNDA. Another sNDA is under review seeking label expansion of Rinvoq in ankylosing spondylitis.
Impact on AbbVie
AbbVie has two drugs in its portfolio — Rinvoq and Skyrizi — which hold the potential to become alternatives to its multi-indication drug, Humira. The company’s majority of revenues comes from Humira. However, the drug is set to face generic competition in the United States, beginning 2023. In the EU, several biosimilars of Humira are already unveiled by companies, including Amgen (AMGN - Free Report) and Biogen (BIIB - Free Report) , which significantly lowered the international sales of Humira. A similar scenario in the United States beyond 2023 will significantly dent AbbVie’s revenues. Successful developments of Rinvoq and Skyrizi in ongoing clinical studies followed by potential label expansions and continued demand in launched indications will be key to AbbVie’s long-term growth, as these drugs have the potential to offset the loss of Humira sales, going forward.
However, some recent negative developments related to Rinvoq and JAK inhibitors raise concerns for the future of the drug and its impact on the company’s top-line growth. Meanwhile, such news is unlikely to affect the prospects of Skyrizi, an interleukin-23 antagonist.
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AbbVie (ABBV) Down as FDA Extends Review of Rinvoq sNDA
AbbVie (ABBV - Free Report) announced that the FDA has extended the review period fora supplemental new drug application (sNDA) for its JAK-inhibitor drug, Rinvoq (upadacitinib), by three months. The sNDA is seeking label expansion of Rinvoq to treat patients with active psoriatic arthritis. A decision from the FDA is now expected by the end of the second quarter.
Shares of AbbVie declined 5.2% on Mar 17 following the announcement. In fact, the company’s shares have decreased 1.9% so far this year against the industry’s 0.5% growth.
Why the Extension
Recently, the FDA has requested the company to provide updated data on the benefit-risk profile of Rinvoq in psoriatic arthritis. The company submitted the requested data, following which the regulatory authority decided to extend the review period for the sNDA for the full review of the data.
Some analysts are wondering whether the requirement for additional safety data on Rinvoq is related to concerns about JAK inhibitors. Recently, the FDA issued a statement that Pfizer’s (PFE - Free Report) JAK inhibitor, Xeljanz, may increase the risk of heart-related problems and cancer. The statement was based on data from a study that compared the drug to another class of drugs — tumor necrosis factor (TNF) inhibitors. Analysts believe that the extension in the Rinvoq sNDA review period might be due to the spill-over effect of the Xeljanz study, as boththe drugs are JAK inhibitors.
We note that Rinvoq is already approved as an oral, once-daily treatment for rheumatoid arthritis (RA) in the United States and Europe. The drug is also approved for treating psoriatic arthritis and ankylosing spondylitis in Europe. However, the drug’s label includes warnings about serious infections, including blood clots and cancer. A FDA decision to include strict warnings for serious health hazards in the anticipated label for psoriatic arthritis is likely to hamper the drug’s prospects.
Moreover, another sNDA seeking the label expansion for Rinvoq to treat adult patients (15 mg and 30 mg) and adolescents (15 mg) with moderate-to-severe atopic dermatitis or eczema is under review. The FDA has requested to provide similar updated data on the benefit-risk profile of Rinvoq in this patient populations as well. AbbVie is preparing the requested data and will submit them to the FDA shortly. This submission may also lead to the extension of the review period for the eczema sNDA. Another sNDA is under review seeking label expansion of Rinvoq in ankylosing spondylitis.
Impact on AbbVie
AbbVie has two drugs in its portfolio — Rinvoq and Skyrizi — which hold the potential to become alternatives to its multi-indication drug, Humira. The company’s majority of revenues comes from Humira. However, the drug is set to face generic competition in the United States, beginning 2023. In the EU, several biosimilars of Humira are already unveiled by companies, including Amgen (AMGN - Free Report) and Biogen (BIIB - Free Report) , which significantly lowered the international sales of Humira. A similar scenario in the United States beyond 2023 will significantly dent AbbVie’s revenues. Successful developments of Rinvoq and Skyrizi in ongoing clinical studies followed by potential label expansions and continued demand in launched indications will be key to AbbVie’s long-term growth, as these drugs have the potential to offset the loss of Humira sales, going forward.
However, some recent negative developments related to Rinvoq and JAK inhibitors raise concerns for the future of the drug and its impact on the company’s top-line growth. Meanwhile, such news is unlikely to affect the prospects of Skyrizi, an interleukin-23 antagonist.
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Zacks Rank
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
AccessZacks Top 10 Stocks for 2021 today >>