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FDA Warns Doctors After 19 Deaths on Intercept Liver Drug

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  • Some patients died after taking excessive doses, agency says
  • Drugmaker stock drops almost 25 percent, the most since 2014

Nineteen patients died after taking a liver-disease drug from Intercept Pharmaceuticals Inc., the U.S. Food and Drug Administration said, warning doctors about risks from a product that the company is seeking to make into a blockbuster.

Shares of the drugmaker sank 24.9 percent to $73.70 at 4:00 p.m. in New York, the company’s biggest loss since November 2014.

While the cause of death wasn’t available in most cases, seven of the patients who died were taking the drug, Ocaliva, more frequently than is recommended, the agency said in a safety announcement Thursday.

The drug “is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death,” the FDA said in its warning. But it also said that the medication may be associated with liver damage in some patients with mild disease receiving the correct dose.

Intercept declined to immediately comment as it reviewed the FDA’s statement.

The deaths could lead to restrictions on how Ocaliva is prescribed and additional warnings on the drug’s label, which doesn’t currently list death as a risk. The company would face a potential major safety issue as it tries to expand the drug’s use to millions of patients with other conditions.

Joseph Schwartz, an analyst at Leerink Partners, said that the new information “could tilt the FDA more toward a black box warning” calling attention to life-threatening risks.

Earlier this month, Intercept said it had reviewed 10 deaths of patients who had taken the drug. The company warned doctors that Ocaliva can cause injuries, organ failure, or death if it’s not used exactly as intended in patients with primary biliary cholangitis, a relatively rare liver condition for which the drug was approved last year.

About 15,000 prescriptions for Ocaliva have been written since it was introduced, according to data from Symphony Health Solutions compiled by Bloomberg Intelligence. The drug is Intercept’s only commercial product and was approved in the U.S. in May last year. It brought in $30.4 million in sales last quarter.

Rival treatments in testing at other drugmakers could threaten Ocaliva’s market potential if they don’t have the same risks. Intercept is in the final stages of testing Ocaliva for nonalcoholic steatohepatitis, or NASH, which is associated with being overweight. 

Three percent to 12 percent of Americans have NASH, according to the U.S. National Institutes of Health -- a huge potential market. Analysts have projected that the drug will become a blockbuster, with more than $1 billion in sales by 2021, though the disclosure of deaths may change that.

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