Amgen to terminate participation in co-development of brodalumab

Amgen announced that it has commenced terminating its participation in the co-development and commercialization of brodalumab with AstraZeneca for treating moderate-to-severe plaque psoriasis, psoriatic arthritis and spondyloarthritis, according to a press release.

The decision about the investigational interleukin-17 receptor inhibitor was “based on events of suicidal ideation and behavior in the brodalumab program which Amgen believes likely would necessitate restrictive labeling,” the release stated.

“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, MD, executive vice president of Research and Development at Amgen, said in the release.

AstraZeneca will have sole discretion on future decisions on clinical development and marketing submissions for all markets except certain Asian territories, including Japan, where Kyowa Hakko Kirin has the rights to brodalumab, according to the release.

AstraZeneca reported in a separate press release that it will base its decision on future development of brodalumab on further review of data.

“Data from the three AMAGINE Phase III pivotal studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit,” Briggs Morrison, MD, executive vice president, Global Medicines Development, and chief medical officer at AstraZeneca, said in the release. “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 had formed a collaboration in April 2012 to jointly develop and commercialize five monoclonal antibodies from Amgen’s clinical inflammation portfolio, the releases stated.

Reference: www.amgen.com, www.astrazeneca.com