Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Concerned As Experimental Psoriasis Drug Linked To Suicide Risk

XTALKS VITALS NEWS

FDA

During clinical trials of the treatment, six participants committed suicide but the FDA said a lack of data made it difficult to determine the events’ effect on drug safety.

Tweetables from this article:

Tweet: During #clinicaltrial of Valeants' psoriasis drug six participants committed suicide http://ctt.ec/TP2Ui+During clinical trial of Valeants' psoriasis drug six participants committed suicide.

Tweet: Valeant holds the US, non-Japanese, and non-European market rights for brodalumab http://ctt.ec/PRk2T+Valeant holds the US, non-Japanese, and non-European market rights for brodalumab.

Share this!

July 19, 2016 | by Sarah Massey, M.Sc.

In advance of an advisory panel meeting, the US Food and Drug Administration (FDA) has released documents regarding the safety of an experimental psoriasis drug in development by Valeant Pharmaceuticals. During clinical trials of the treatment, six participants committed suicide but the FDA said a lack of data made it difficult to determine the events’ effect on drug safety.

After a Phase III clinical trial indicated that the drug was effective at treating moderate-to-severe plaque psoriasis, Valeant ended the study ahead of schedule. Valeant acquired the drug – called brodalumab – late last year from AstraZeneca, paying $100 million for the global rights. AstraZeneca recently backed out of that agreement, instead granting LEO Pharma exclusive European rights to the drug.

In two Phase III clinical trials, brodalumab proved more effective that the placebo, as measured by the Psoriasis Area and Severity Index (PASI) score. What’s more, the drug also showed increased efficacy over Johnson and Johnson's psoriasis drug, Stelara, in an additional 12-week clinical trial. The FDA advisory panel is set to review brodalumab today.

In all, four participants committed suicide during the three Phase III clinical trials, along with two individuals in previous studies. While of the suicide cases was thought to be the result of an accidental drug overdose, the events still elicited safety concerns from the FDA.



In addition to the suicide connection, FDA reviewers were also concerned that the psoriasis drug could raise the risk of cardiovascular events in those taking the drug. As a monoclonal antibody, brodalumab disrupts the interleukin-17 receptor A (IL-17RA), a part of the pathway thought to be involved in the pathogenesis of psoriasis.

“The available data raise concerns about a potential interaction with cytokines in the central nervous system and an impact on cardiovascular atherosclerosis,” said the FDA report. “Limited controlled data in the brodalumab development program for these uncommon events makes the assessment of risk-benefit for brodalumab challenging.”

Former Valeant CEO, Michael Pearson was optimistic when the rights to the drug was first acquired from AstraZeneca. “We are delighted we were able to reach a licensing agreement with AstraZeneca to commercialize brodalumab, which is potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis,” said Pearson. However, as AstraZeneca has ended the licensing agreement, Valeant only holds the US, non-Japanese, and non-European market rights for brodalumab.

Regardless of its success at today’s safety hearing, Valeant is expected to face some formidable opponents in the psoriasis space. Two new IL-17A antagonists, Novartis’ Cosentyx and Eli Lilly’s Taltz, have recently won FDA approval.


Keywords: FDA, Psoriasis, Drug Safety


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Gilead’s Newest Hepatitis C Drug Gets FDA Approval

July 21, 2017 - Dominant player in the chronic hepatitis C virus (HCV) market Gilead has received US Food and Drug Administration (FDA) approval for its newest treatment, Vosevi.

Featured In: Pharmaceutical News


Detecting Alzheimer’s Biomarkers in the Blood Could Improve Early Diagnosis

July 20, 2017 - In an effort to improve rates of early diagnosis and intervention, researchers at Washington University in St. Louis have developed a blood test that can detect some of the hallmarks of Alzheimer’s disease.

Featured In: Biotech News


Insurance Coverage Under the Affordable Care Act Supports Clinical Trial Enrollment, Says Study

July 20, 2017 - Since the Patient Protection and Affordable Care Act (ACA) was passed in 2010, insurance approval for patients wishing to participate in oncology clinical trials has increased, according to a recent study published in the journal, Clinical Cancer Research.

Featured In: Clinical Trial News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Manufacturing Control Strategies: What Pharmaceutical and Biotech Companies Need to Know

REGISTER FOR THESE WEBINARS

Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned


EDC and eSource: Combined for Better Data and Faster Insights


Using Model Reduction to Bridge the Quality Systems Pharmacology-Pharmacometrics Divide


How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology


Copyright © 2016-2017 Honeycomb Worldwide Inc.