Psoriasis Drug Development Pact Dissolved Due to Suicide Concerns
Amgen has terminated its co-development and commercialization of brodalumab with AstraZeneca after observing suicidal ideation and behavior in clinical trial participants.
Amgen has terminated its co-development and commercialization of brodalumab with AstraZeneca after observing suicidal ideation and behavior in clinical trial participants that could result in restrictive drug 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 Sean E. Harper, MD, executive vice president of research and development at Amgen, in a statement.
Brodalumab is an interleukin-17 receptor inhibitor in development to treat moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. By blocking this receptor, the drug prevents the body from receiving signals that may lead to inflammation.
AstraZeneca plans to further review data from brodulamub’s clinical trials and decide on the drug’s future development as soon as possible.
“Data from the 3 AMAGINE phase 3 pivotal studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit,” said Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca, in a separate statement. “We will fully evaluate the data and assess all options before we make our independent decision about the future of this potential medicine.”
Amgen and AstraZeneca partnered back in April 2012 to jointly develop and commercialize 5 monoclonal antibodies from Amgen’s clinical inflammation portfolio, including brodalumab. After Amgen transitions the research program to AstraZeneca, future decisions on brodalumab’s development and regulatory applications will be at the sole discretion of AstraZeneca worldwide, except for certain Asian territories.