
Valeant’s psoriasis drug “difficult to assess”, according to FDA staff
pharmafile | July 18, 2016 | News story | Research and Development, Sales and Marketing | FDA, Valeant, psoriasis
Staff at the US Food and Drug Administration have expressed concerns over Valeant’s psoriasis candidate, brodalumab, due to the potential risk of suicide associated with the drug, with the lack of relevant data making the drug difficult to assess.
The fate of this drug as it comes before the regulator is potentially crucial for Valeant, as it looks to reverse recent trends of falling stock prices and revenue.
The FDA committee noted that the limited data meant that “[they] cannot conclude whether or not suicide is a drug-related risk.” While label warnings and strategies can help mitigate the risk, the committee point out that “no risk management strategy will completely eliminate the risk.”
Valeant acquired the drug from AstraZeneca in 2015, after Amgen quit its brodalumab collaboration following six suicides among trial patients.
With brodalumab potentially containing boxed warnings, as well as joining a crowded psoriasis market, Valeant’s problems may not be solved even if the FDA decides to approve the drug.
Sean Murray
Related Content

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …

Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …

Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …






