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AbbVie's (ABBV) Rinvoq sNDA Decision Delayed by the FDA
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AbbVie (ABBV - Free Report) has announced that the FDA will not give its decision on the supplemental new drug applications (sNDAs) of its JAK inhibitor drug, Rinvoq (upadacitinib), on the Prescription Drug User Fee Act (PDUFA) action dates. Notably, the sNDAs are seeking approval for the drug’s use for active psoriatic arthritis and active ankylosing spondylitis in adults.
Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis. Though the FDA has not taken any formal action like delaying the PDUFA date, it informed AbbVie that it is currently reviewing Pfizer’s (PFE - Free Report) post-marketing study, ORAL Surveillance, on marketed JAK inhibitor, Xeljanz (tofacitinib), in patients with rheumatoid arthritis, which it cited as the reason for the delay.
We remind investors that earlier this year the FDA had extended the review timeline for Rinvoq sNDAs for active psoriatic arthritis as well as for atopic dermatitis (AD) by three months citing that it needs time to review some additional information submitted by the company. A decision on these sNDAs was expected in late second-quarter 2021.
Regulatory applications seeking approval of Rinvoq for ankylosing spondylitis, active psoriatic arthritis and atopic dermatitis are under review in the United States.
AbbVie’s stock has risen 5.5% this year so far compared with an increase of 8.2% for the industry.
Image Source: Zacks Investment Research
AbbVie is not the only company that has faced FDA delays in 2021 regarding JAK inhibitor pipeline drugs. In April, the FDA extended the review timeline for Lilly (LLY - Free Report) and partner Incyte’s (INCY - Free Report) sNDA for their oral JAK inhibitor, Olumiant, in atopic dermatitis by three months.
In April, it extended the review timeline of Pfizer’s NDA for abrocitinib, an investigational oral JAK inhibitor for moderate-to-severe AD, by three months. The FDA also extended the review period for Pfizer’s sNDA seeking approval of Xeljanz for the treatment of active ankylosing spondylitis by three months.
The extension of review periods for sNDAs and other negative updates about JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs. JAK inhibitors work by blocking a particular signal of a body’s immune response, cytokines, instead of suppressing the immune system as done by DMARDs. However, this class of drugs comes with its share of side effects including risk of serious infections, malignancies and thrombosis. Some of these side effects are mentioned as boxed warnings in labels of marketed JAK inhibitor drugs.
Rinvoq is a key new drug in AbbVie’s portfolio, which along with another new drug Skyrizi, is gradually lowering AbbVie’s dependence on main immunology medicine, Humira. AbbVie was expecting that with many new indications expected to be approved in the next couple of years, sales of these drugs could be higher and have the potential to replace Humira when generics are launched in 2023. AbbVie expects combined revenues of these two drugs to be more than $15 billion by 2025. However, with the delay in FDA decision on Rinvoq sNDAs and uncertain environment for JAK inhibitor drugs, AbbVie might not be able to meet its sales target for the drug. Rinvoq generated sales of $731 million in 2020.
Regarding, Pfizer’s post-marketing study, we remind investors that in February, Pfizer made some modifications to the study. Pfizer, back then, said it will transition study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily — an FDA approved dose — due to notification from the tofacitinib Rheumatology Data Safety Monitoring Board (DSMB) of a safety signal in the 10 mg twice daily treatment arm
In a separate press release, AbbVie announced that European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Rinvoq for adults and adolescents with moderate to severe AD.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
Image: Bigstock
AbbVie's (ABBV) Rinvoq sNDA Decision Delayed by the FDA
AbbVie (ABBV - Free Report) has announced that the FDA will not give its decision on the supplemental new drug applications (sNDAs) of its JAK inhibitor drug, Rinvoq (upadacitinib), on the Prescription Drug User Fee Act (PDUFA) action dates. Notably, the sNDAs are seeking approval for the drug’s use for active psoriatic arthritis and active ankylosing spondylitis in adults.
Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis. Though the FDA has not taken any formal action like delaying the PDUFA date, it informed AbbVie that it is currently reviewing Pfizer’s (PFE - Free Report) post-marketing study, ORAL Surveillance, on marketed JAK inhibitor, Xeljanz (tofacitinib), in patients with rheumatoid arthritis, which it cited as the reason for the delay.
We remind investors that earlier this year the FDA had extended the review timeline for Rinvoq sNDAs for active psoriatic arthritis as well as for atopic dermatitis (AD) by three months citing that it needs time to review some additional information submitted by the company. A decision on these sNDAs was expected in late second-quarter 2021.
Regulatory applications seeking approval of Rinvoq for ankylosing spondylitis, active psoriatic arthritis and atopic dermatitis are under review in the United States.
AbbVie’s stock has risen 5.5% this year so far compared with an increase of 8.2% for the industry.
AbbVie is not the only company that has faced FDA delays in 2021 regarding JAK inhibitor pipeline drugs. In April, the FDA extended the review timeline for Lilly (LLY - Free Report) and partner Incyte’s (INCY - Free Report) sNDA for their oral JAK inhibitor, Olumiant, in atopic dermatitis by three months.
In April, it extended the review timeline of Pfizer’s NDA for abrocitinib, an investigational oral JAK inhibitor for moderate-to-severe AD, by three months. The FDA also extended the review period for Pfizer’s sNDA seeking approval of Xeljanz for the treatment of active ankylosing spondylitis by three months.
The extension of review periods for sNDAs and other negative updates about JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs. JAK inhibitors work by blocking a particular signal of a body’s immune response, cytokines, instead of suppressing the immune system as done by DMARDs. However, this class of drugs comes with its share of side effects including risk of serious infections, malignancies and thrombosis. Some of these side effects are mentioned as boxed warnings in labels of marketed JAK inhibitor drugs.
Rinvoq is a key new drug in AbbVie’s portfolio, which along with another new drug Skyrizi, is gradually lowering AbbVie’s dependence on main immunology medicine, Humira. AbbVie was expecting that with many new indications expected to be approved in the next couple of years, sales of these drugs could be higher and have the potential to replace Humira when generics are launched in 2023. AbbVie expects combined revenues of these two drugs to be more than $15 billion by 2025. However, with the delay in FDA decision on Rinvoq sNDAs and uncertain environment for JAK inhibitor drugs, AbbVie might not be able to meet its sales target for the drug. Rinvoq generated sales of $731 million in 2020.
Regarding, Pfizer’s post-marketing study, we remind investors that in February, Pfizer made some modifications to the study. Pfizer, back then, said it will transition study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily — an FDA approved dose — due to notification from the tofacitinib Rheumatology Data Safety Monitoring Board (DSMB) of a safety signal in the 10 mg twice daily treatment arm
In a separate press release, AbbVie announced that European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Rinvoq for adults and adolescents with moderate to severe AD.
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 3 crypto-related stocks now >>
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
See 3 crypto-related stocks now >>