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Wednesday, March 17, 2021 10:53:55 AM
AbbVie (ABBV) Slumps After FDA Extends Psoriatic Arthritis Drug Review
By: TheStreet | March 17, 2021
AbbVie (ABBV) shares slumped sharply lower Wednesday after the Food & Drug Administration extended its review of the drugmaker's developing psoriatic arthritis treatment.
AbbVie said the FDA asked for a three-month extension to its New Drug Application after receiving requests for more information and an updated benefit-risk profile for the use of upadacitinib, known by its brand name Rinvoq, in the treatment of adult patients with active psoriatic arthritis.
Rinvoq, a key driver of future revenue growth for AbbVie, was granted FDA approval for the treatment of rheumatoid arthritis in 2019. Analysts had hoped that expanded authorization for Rinvoq would help soften the blow of the loss of patent protection for Humira, its Crohn's disease treatment, which expires in 2023.
Skyrizi, a treatment for moderate to severe plaque psoriasis, is another key treatment for AbbVie and is a collaboration between AbbVie and Germany's Boehringer Ingelheim. AbbVie leads development and commercialization of the product worldwide.
"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," said AbbVie president Michael Severino.
Abbvie shares were marked 6.3% lower in early trading Wednesday to change hands at $103.95 each. The move also trims the stocks' six-month gain to around 16% and values the North Chicago, Illinois-based biotech at around $182.5 billion.
Last month, AbbVie posted stronger-than-expected fourth quarter sales of $13.9 billion, with sales of Humira rising 4.8% to $5.15 billion.
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By: TheStreet | March 17, 2021
AbbVie (ABBV) shares slumped sharply lower Wednesday after the Food & Drug Administration extended its review of the drugmaker's developing psoriatic arthritis treatment.
AbbVie said the FDA asked for a three-month extension to its New Drug Application after receiving requests for more information and an updated benefit-risk profile for the use of upadacitinib, known by its brand name Rinvoq, in the treatment of adult patients with active psoriatic arthritis.
Rinvoq, a key driver of future revenue growth for AbbVie, was granted FDA approval for the treatment of rheumatoid arthritis in 2019. Analysts had hoped that expanded authorization for Rinvoq would help soften the blow of the loss of patent protection for Humira, its Crohn's disease treatment, which expires in 2023.
Skyrizi, a treatment for moderate to severe plaque psoriasis, is another key treatment for AbbVie and is a collaboration between AbbVie and Germany's Boehringer Ingelheim. AbbVie leads development and commercialization of the product worldwide.
"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," said AbbVie president Michael Severino.
Abbvie shares were marked 6.3% lower in early trading Wednesday to change hands at $103.95 each. The move also trims the stocks' six-month gain to around 16% and values the North Chicago, Illinois-based biotech at around $182.5 billion.
Last month, AbbVie posted stronger-than-expected fourth quarter sales of $13.9 billion, with sales of Humira rising 4.8% to $5.15 billion.
Read Full Story »»»
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