FDA to Consider Drug With Suicide Risk
Mesh News Desk, July 15, 2016 ~ FDA will consider approving a drug that has some red flags for its association with a risk of suicide.
The drug is made by Valeant and its called brodalumab.
Last May there were six suicides among the clinical trials. That prompted drugmaker Amgen to back out on its collaboration with AstraZeneca. The rights were then sold to Valeant.
It’s now up to an expert panel of the US Food and Drug Administration to decide whether brodalumab should be approved for sale.
The company admits there is limited data to assess the risk.
Brodalumab is a monoclonal antibody used to treat inflammatory diseases including psoriasis.
The FDA’s briefing documents are here.
Tuesday, July 19, the FDA panel of experts will meet. The FDA does not have to follow the recommendation of its experts, but usually does.
Read more on Fierce Pharma. ##