Fragile Drug Development Process

We are currently in the midst of a new wave of drug developments and approvals for psoriasis; however, we recently have been reminded of the tenuous nature of bringing a new drug to market. Last month, Amgen Inc announced it was pulling out of the long-running collaboration on the high-profile IL-17 program after evaluating the likely commercial impact it would face in light of the suicidal thoughts some patients reported during the studies.

Brodalumab had successfully completed 3 phase 3 studies in patients with moderate to severe plaque psoriasis known as the AMAGINE program. Top-line results from AMAGINE-1 comparing brodalumab with placebo were released in May 2014. Top-line results from AMAGINE-2 and AMAGINE-3 comparing brodalumab with ustekinumab and placebo were announced in November 2014. AMAGINE-2 and AMAGINE-3 are identical in design. “During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab,” said Amgen Executive Vice President of Research and Development Sean Harper in a statement. AstraZeneca must now decide whether to pursue brodalumab independently.

Once the exact data are publicly released, we will be able to better evaluate the issues of suicidal ideation involved.

What’s the issue?

Brodalumab was eagerly anticipated in the dermatology community. In an instant, the drug’s future is in doubt, which once again demonstrates the fragility of the drug development process. How will this recent announcement affect your use of new biologics?

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