Updated on 27 May 2015
Brodalumab is an investigational IL-17 inhibitor for patients with plaque psoriasis
Singapore: Amgen has terminated the partnership with AstraZeneca for co-development and commercialization of brodalumab, an investigational IL-17 inhibitor for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate 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," said Dr Sean E Harper, executive vice president, research and development, Amgen.
After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab.
In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio.