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