05.27.15
Amgen has terminated its participation in the co-development and commercialization of brodalumab under its collaboration with AstraZeneca after events of suicidal ideation and behavior in the brodalumab program, which the company believes would restrict labeling. Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
AstraZeneca will now be responsible for the clinical development and submission of marketing applications for brodalumab for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab.
"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Sean E. Harper, M.D., executive vice president of R&D at Amgen.
AstraZeneca will now be responsible for the clinical development and submission of marketing applications for brodalumab for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab.
"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Sean E. Harper, M.D., executive vice president of R&D at Amgen.