July 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Federal regulators are split over how to proceed with Valeant ’s plaque psoriasis treatment, brodalumab, due to a possible link with suicidal tendencies.
The question of the drug’s safety is causing the rift between members of a U.S. Food and Drug Administration advisory panel, Bloomberg reported on Friday. During clinical trials, there were 23 deaths associated with the drug, including four suicides, according to the FDA panel’s report. The report also detailed that at least 11 patients exhibited suicidal behavior.
The regulatory officials, representing eight different divisions, said psychiatric and psychological factors play an important role in at least 30 percent of dermatological disorders.
“Patients with psoriasis have a particularly high rate of psychiatric morbidity, including depression, anxiety, suicidal ideation and suicidal behavior, substance use disorders, and other psychiatric disorders. Furthermore, the prevalence of mood symptoms in psoriasis is higher than that observed in many other disfiguring skin disorders,” the panel said in its report. Not only is the question of suicidal behavior concerning, but so were the number of deaths related to cardiovascular issues. Of the 23 deaths, 13 were related to cardiovascular issues.
Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. The drug blocks the binding of several IL-17 cytokines to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestations of plaque psoriasis. During late-stage clinical trials brodalumab taken at a dose of 210 milligrams, was shown to be effective in treating psoriasis.
Valeant acquired the drug last year from AstraZeneca in a deal worth up to $445 million. The Canadian-based pharmaceutical company made an upfront payment of $100 million for the drug. At the time of the deal, J. Michael Pearson, then the chief executive officer of Valeant, said brodalumab is “potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis.”
Brodalumab was originally a joint project between AstraZeneca and Amgen . However, on May 22 Amgen stepped away from the agreement concerning Brodalumab after patients showed signs of suicidal tendencies, which would require a stringent warning label if the drug achieved regulatory approval. During trials, four patients showed suicidal tendencies and two patients committed suicide. When Amgen announced it was terminating the collaboration, the company also said there were additional suicides in the open label extension studies, beyond the two reported in the Phase III studies.
After Amgen stepped away from the collaboration, Pascal Soiriot, AstraZeneca’s CEO, said the company wanted to take some time to look at the data and talk things over with regulatory authorities and see if there is a clear path forward to bringing the drug to market. That path seemed to be selling the drug to deal-hungry Valeant.
If the drug is ultimately approved by the FDA later this week, it could potentially come with a black-box warning label, which has the possibility of hampering sales, especially considering Novartis already markets a similar psoriasis drug called Cosentyx that does not come with suicidal side effects. In May, the FDA approved Eli Lilly ’s Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. That medication was also approved without a warning label.
