Intercept sinks after FDA safety communication cites 19 patient deaths
The FDA, in its safety communication sent out today on Intercept Pharmaceuticals' Ocaliva, said it identified 19 cases of death, of which eight provided information about the cause. Intercept on September 12 told Bloomberg that 10 patients died while taking Ocaliva. In the 13 months after Ocaliva was approved in May 2016, the FDA says it received reports of serious liver injury or death associated with the drug. The cause of death was reported to be worsening of primary biliary cholangitis disease in seven cases, with cardiovascular disease cited in the other case. Seven of these eight cases described patients with moderate to severe decreased liver function who received Ocaliva 5 mg daily, instead of a dose no greater than 10 mg twice weekly as recommended in the label prescribing information for patients with this extent of decreased liver function, the agency said in its communication. Shares of Intercept are down 7%, or $6.72, to $91.40 in late morning trading.