Valeant Pharmaceuticals Intl Inc. (NYSE: VRX) has faced a headwind as its brodalumab will obtain a label warning because of the issue involving suicidal and behavioral thoughts in patients who are currently undergoing the clinical trials on the said drug, according to a staff of the Food and Drug Administration. The brodalumab is an investigational drug, which was developed for the treatment and management of psoriasis. The mentioned drug has been scheduled to be under advisory panel review on July 19.
Brodalumab is categorized under monoclonal antibody, which basically blocks the interleukin-17 receptor A. Because of the issues related to the safety of the drugs, eight units of the Food and Drug Administration were engaged in the pharmacovigilance related to the suicidality of brodalumab. The participants who are enrolled in the clinical trials of the drug are also observed to have psychiatric morbidity, such as anxiety, suicidal behavior, depression, and suicidal ideation, substance use disorders, as well as other psychiatric disorders.
During the trials, 6 participants committed suicide, which makes brodalumab’s drug profile suspicious. Among the 6 participants, 4 were involved in the study on psoriasis, 1 in the psoriatic arthritis study, and 1 in the rheumatoid arthritis clinical study.
Aside from this, the absence of scientific clinical data has put obstacles when it comes to sorting the drug’s safety parameters. Valeant pharmaceutical has stopped the Phase 3 trial of the said drug after obtaining comprehensive results in terms of the treatment of moderate to severe plaque psoriasis, which was gauged by the Psoriasis Area and Severity Index score.
According to the Food and Drug Administration, “We have uncertainty about whether the signal for completed suicide is a risk related to brodalumab treatment.”
“From the available data, we cannot conclude whether or not suicide is a drug-related risk,” the FDA further added.
Furthermore, the researcher indicated that the prescribing physician will not be aware of the diagnosing and screening processes for the suicidality of the drug. The FDA staff is not certain regarding the role of the mentioned drug when it comes to triggering cardiovascular risk.
“The biologic effects of the resulting increase in serum IL-17A and its interaction with other cytokines are not well understood; however, the available data raise concerns about a potential interaction with cytokines in the central nervous system and an impact on cardiovascular atherosclerosis. Limited controlled data in the brodalumab development program for these uncommon events makes the assessment of risk–benefit for brodalumab challenging,” the staff concluded.
The investigational drug was mutually developed by AstraZeneca and Amgen. However, during the month of May last year, Amgen withdrew because of the potential suicide risks during the clinical trials. At the start, AstraZeneca shared the global rights of the investigational drug to Valeant Pharmaceuticals. However, because of the scandal regarding the price increase and its suspect association with the speciality pharmacy, it ended the license of Valeant for the commercialization and marketing of of brodalumab in Europe and allocated the rights to LEO Pharma.
As of the time of writing, VRX shares are changing hands at $22.86, down by 0.70 percent or 0.16.