Amgen Terminates Co-Development of Brodalumab with AstraZeneca
Amgen ended its co-development of brodalumab with AstraZeneca after some patients who took the experimental psoriasis drug experienced suicidal thoughts or behavior, which Amgen believes would likely require restrictive labeling.
Brodalumab, the interleukin-17 (IL-17) inhibitor, has been in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
“During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab,” Sean E. Harper, M.D., executive vice president of research and development at Amgen, said in a company statement.
Amgen said it will transition the program to AstraZeneca, which will make future decisions on the clinical development and submission of marketing applications for brodalumab — except for areas within Asia, including Japan, where Kyowa Hakko Kirin holds rights to the compound.
As a result, Amgen said it will focus on developing other drugs. AstraZeneca said it will review data from the clinical trial before it decides whether it will continue developing the drug.
Brodalumab is one of five monoclonal antibodies from Amgen’s clinical information portfolio that the company agreed to jointly develop and commercialize under a $50 million collaboration launched in 2012.
Brodalumab is designed to work by inhibiting inflammatory signaling by blocking the molecule interleukin-17 (IL-17).
Novartis already markets a psoriasis drug called Cosentyx (secukinumab) that binds to a related protein, IL-17A. Eli Lilly has in development an IL-17 inhibitor for psoriasis, ixekizumab, which it aims to submit for approval mid-year..
Amgen’s shares slipped 2.8% on Tuesday, while AstraZeneca’s stock was down 2.5%.