FDA staff raises safety concerns for Valeant psoriasis drug
- Food and Drug Administration staff raised safety concerns about an experimental psoriasis drug from Valeant Pharmaceuticals, highlighting a potential risk of suicide in documents posted ahead of an advisory panel review scheduled for next Tuesday.
- The staff report noted six people had completed suicide during clinical testing of the drug but said a lack of data made it difficult to assess the safety implications. Valeant had stopped Phase 3 trials of the drug early after results indicated the drug was effective against moderate-to-severe plaque psoriasis.
- Valeant last fall had paid AstraZeneca $100 million upfront for exclusive global rights to the drug, called brodalumab, excluding Japan and some other Asian markets. But AstraZeneca recently changed that licensing agreement, handing European rights to the drug to LEO Pharma instead.
An independent advisory panel will review brodalumab on July 19. The mixed review from FDA staff makes brodalumab's fate before the panel more uncertain.
Brodalumab proved more effective in treating moderate-to-severe plaque psoriasis than placebo in two Phase 3 trials, as measured by the Psoriasis Area and Severity Index (PASI) score. Brodalumab also bested Johnson and Johnson's Stelara after 12 weeks in a third trial.
But four people completed suicide in the three Phase 3 trials, adding to two other suicides from previous trials. One suicide was judged to be due to a possible accidental drug overdose but the suicides raised a red flag for FDA reviewers.
Additionally, FDA staff were unsure if brodalumab's method of action could raise the risk of cardiovascular adverse events.
"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 report said.
Brodalumab is a monoclonal antibody which blocks the interleukin-17 receptor A (IL-17RA).
When Valeant picked the drug up from AstraZeneca, now-former CEO Michael Pearson sung its praises saying, "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."
After AstraZeneca terminated the licensing agreement to brodalumab in Europe, Valeant now only has rights to the drug in te U.S. and non-European, non-Japan markets.
But even if the advisory panel is able to look past the safety concerns for the drug, Valeant will face tough competition in the psoriasis market. Novartis and Eli Lilly have both recently won approval for their IL-17A antagonists Cosentyx and Taltz, respectively.
Now under the leadership of Joseph Papa, Valeant has been working to recover from a disastrous start to 2016. While it has put its financial reporting in order and closed out an investigation into its accounting practices, the company is still struggling with roughly $30 billion in debt and ongoing scrutiny over pricing. A rejection of brodalumab next week could draw negative sentiment about the company's prospects back to the surface.
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