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 The drug, upadacitinib, is a once-daily pill belonging to a class of
drugs known as JAK inhibitors, which block inflammation-causing
enzymes called Janus kinases.
Pfizer Inc's Xeljanz is the only U.S.-approved JAK inhibitor for
rheumatoid arthritis – a chronic inflammatory disease in which the
immune system attacks tissues in the joints, affecting more than 23
million people.
AbbVie's success comes almost two months after the U.S. Food and
Drug Administration rejected baricitinib, a rival JAK inhibitor
developed by Eli Lilly and Co and Incyte Corp.
If approved, upadacitinib could help AbbVie lower its reliance on
its flagship rheumatoid arthritis drug Humira – the world's top
selling medicine that will soon face competition from biosimilars in
the United States.
AbbVie's shares were up 1.4 percent at $68.81 on Wednesday
afternoon. They earlier hit a session high of $69.32, their highest
since August 2015.
In AbbVie's 12-week study on upadacitinib, two doses of the drug
were tested against a placebo on patients with moderate-to-severe
rheumatoid arthritis.
AbbVie said 64 percent of patients given a 15-milligram dose and 66
percent of patients given a 30-mg dose experienced a 20 percent
reduction in symptoms, measured using a commonly used rheumatoid
arthritis scale.
The company said only 36 percent of patients given a placebo
experienced a comparable drop in symptoms, meaning upadacitinib
cleared the trial – the first of six testing the drug on patients
with various cases of rheumatoid arthritis.
As data from the other trials comes in, upadacitinib might prove to
be more effective than Lilly and Incyte's baricitinib, Jefferies
analyst Jeffrey Holford said.
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Rheumatoid arthritis is currently treated with older drugs such as
methotrexate, Pfizer's JAK inhibitor Xeljanz as well as injected
biologics such as Amgen Inc's Enbrel and AbbVie's Humira.
Humira generated more than $16 billion in sales last year, but
competition is looming. AbbVie is trying to block the launch of an
FDA-approved biosimilar, made by Amgen, arguing that its patents on
Humira offered protection until at least 2022.
AbbVie is also evaluating upadacitinib for several other autoimmune
conditions, including psoriatic arthritis, Crohn's disease and
ulcerative colitis.
Holford estimated peak sales of $3.5 billion for the drug across all
diseases. Pfizer's Xeljanz generated sales of $927 million last
year.
(This story corrects paragraph 3 to clarify that Xeljanz is the only
U.S.-approved JAK inhibitor.)
(Reporting by Divya Grover in Bengaluru, additional reporting by
Natalie Grover; Editing by Sai Sachin Ravikumar and by Savio D'Souza)
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