The Future of Brodalumab Awaits AstraZeneca’s Decision

The US drug maker Amgen has severed ties with its former partner, AstraZeneca, a UK-based drug maker over the issue of restrictive labeling. This marks an end to the collaborative project development and commercialization deal for a drug called Brodalumab.

Brodalumab is a monoclonal antibody, which helps in treating skin disease psoriasis, psoriatic arthritis and axial spondyloarthritis. It was developed by Amgen and was being tested to treat moderate-to-severe conditions.

The two companies entered into a deal in April 2012 and Brodalumab was one of the five drugs to be developed under this deal. The collaborative effort aimed at producing five monoclonal antibodies from Amgen's clinical inflammation portfolio.

Sean E. Harper, Executive Vice President of Research and Development at Amgen, stated, "Agmen's decision was based on events of suicidal ideation and behavior in the Brodalumab program, which Amgen believes likely would necessitate restrictive labeling".

He added that last week, during the preparation process for regulatory submissions, Amgen got to know that the labeling requirements would limit the appropriate patient population for Brodalumab and so the drug developer has decided to terminate the co-development project for this drug.

However, AstraZeneca informed that it has not yet arrived at a decision and will further review the data to chalk out the future development of Brodalumab.

Briggs Morrison, Chief Medical Officer at AstraZeneca and Executive Vice-President for Global Medicines Development stated that data from the AMAGINE Phase III pivotal studies highlighted that Brodalumab has an effective mechanism of action that delivers clinical benefit. Therefore, AstraZeneca will fully evaluate the data and assess all options before it makes an independent decision about the future of this potential medicine. The future of the potential drug thus, awaits AstraZeneca to take charge of it.