Tuesday, 11 August 2020


Amgen terminates AstraZeneca psoriasis drug partnership

27 May 2015 | Regulatory | By BioSpectrum Bureau

Amgen terminates AstraZeneca psoriasis drug partnership

Brodalumab is an investigational IL-17 inhibitor for patients with plaque psoriasis

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.


Sign up for the editor pick and get articles like this delivered right to your inbox.

Editors Pick
+Country Code-Phone Number(xxx-xxxxxxx)


Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account




Podcast

 

Survey Box

Should we be cautious of viewing COVID-19 vaccine as silver bullet?

× Please select an option to participate in the poll.
Processing...   View poll results   More polls

× You have successfully cast your vote.
{{ optionDetail.option }}{{ optionDetail.percentage }}%
{{ optionDetail.percentage }}% Complete
More polls