(Corrects paragraph 3 to clarify that Xeljanz is the only
U.S.-approved JAK inhibitor)
* Upadacitinib, a JAK inhibitor, more effective than a
* FDA had rejected a rival JAK inhibitor drug 2 months back
* Drug could help lower AbbVie's reliance on Humira
* AbbVie shares rise as much as 2.1 pct to 22-month high
By Divya Grover
June 7 AbbVie Inc said on Wednesday its
oral rheumatoid arthritis drug succeeded in a late-stage study
on patients who had not adequately responded to standard
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.
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
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.
(Reporting by Divya Grover in Bengaluru, additional reporting
by Natalie Grover; Editing by Sai Sachin Ravikumar and by Savio