Amgen has ended its co-development of the drug candidate brodalumab with AstraZeneca, citing what it called “events of suicidal ideation and behavior,” that it believed was likely to require restrictive labeling.
The interleukin-17 (IL-17) inhibitor has been in development for indications that include 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., Amgen’s evp of research and development, said in a company statement.
Amgen said it will transition the program to AstraZeneca, which alone will make future decisions on the clinical development and submission of marketing applications for brodalumab—except for Japan and some other areas within Asia, where Kyowa Hakko Kirin holds rights to the compound.
“Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders,” the company said in its statement, released Thursday afternoon. “The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.”
AstraZeneca said in a separate statement that it will confirm its decision on the future development of brodalumab as soon as possible, based on further review of the data
“Data from the three AMAGINE Phase III pivotal studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit. We will fully evaluate the data and assess all options before we make our independent decision about the future of this potential medicine,” added Briggs Morrison, AstraZeneca’s evp, global medicines development and CMO.
Brodalumab is designed to work by binding to the IL-17 receptor and inhibiting inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor.
Amgen halted its co-development of brodalumab four months after the January approvals by the FDA, the European Commission, and Japan’s Ministry of Health, Labour and Welfare of the first IL-17 inhibitor indicated for psoriasis, the Novartis drug Cosentyx (secukinumab).
Another IL-17 inhibitor for psoriasis remains under development, Eli Lilly’s ixekizumab. Last month, Lilly said ixekizumab showed statistical superiority to placebo in the treatment of patients with active psoriatic arthritis (PsA), based on the proportion of patients achieving an ACR 20 response during the 24-week, Phase III SPIRIT-P1 study.
Brodalumab is one of five monoclonal antibodies from Amgen's clinical inflammation portfolio that the company agreed to jointly develop and commercialize under a $50 million collaboration launched in 2012.
Amgen leads clinical development and commercialization for brodalumab and AMG 557/MEDI5872 (Phase Ib for autoimmune diseases, such as systemic lupus erythematosus), under oversight from joint governing bodies, while AstraZeneca leads clinical development and commercialization for MEDI7183/AMG 181 (Phase II for ulcerative colitis and Crohn's disease), MEDI2070/AMG 139 (Phase II for Crohn's disease) and MEDI9929/AMG 157 (Phase II for asthma) through its biologics arm MedImmune.