By Josh Beckerman
Amgen Inc. said it is no longer working with AstraZeneca PLC on
the co-development of brodalumab, a treatment for conditions
including psoriasis, due to safety concerns.
The biotechnology company said the decision was based on "events
of suicidal ideation and behavior" that Amgen believes would lead
to restrictive labeling.
"During our preparation process for regulatory submissions, we
came to believe that labeling requirements likely would limit the
appropriate patient population for brodalumab," Amgen said in a
statement.
AstraZeneca said in a statement that it will "confirm its
decision on the future development of brodalumab as soon as
possible, based on further review of the data." The company noted
the drug's favorable performance in Phase 3 studies and said it
will "fully evaluate the data and assess all options."
In April 2012, Amgen and AstraZeneca formed a collaboration to
jointly develop and commercialize five monoclonal antibodies from
Amgen's portfolio.
Brodalumab, an IL-17 inhibitor, is in development as a treatment
for psoriasis, psoriatic arthritis and axial spondyloarthritis.
Amgen and AstraZeneca said in November that the drug met its
primary endpoints in a Phase 3 trial of patients with
moderate-to-severe plaque psoriasis. The companies said at the time
that the favorable results would form the basis of regulatory
filings planned for 2015.
Write to Josh Beckerman at josh.beckerman@wsj.com
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