Amgen to terminate participation in co-development and commercialisation of brodalumab

Amgen has announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab. 

Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.  The decision was based on events of suicidal ideation and behaviour in the brodalumab programme, which Amgen believes likely would necessitate restrictive labelling.

“During our preparation process for regulatory submissions, we came to believe that labelling requirements likely would limit the appropriate patient population for brodalumab,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.  

AstraZeneca are to evaluate the data for brodalumab before making a decision on the future development of the drug

After Amgen transitions the programme 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. 

AstraZeneca will confirm its decision on the future development of brodalumab as soon as possible, based on further review of the data.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “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.”