(Reuters) - Intercept Pharmaceuticals Inc said on Monday its liver drug, Ocaliva, could carry a boxed warning to help ensure proper dosing but the drugmaker also said it does not expect the updated labeling to be restrictive, sending its shares higher.
Chief Executive Mark Pruzanski said New York-based Intercept was “not anticipating on changes that restrict the use (of the drug) in any part of the population” as of Monday, based on the discussions with the U.S. Food and Drug Administration.
A boxed warning on the label is FDA’s strictest warning and calls attention to serious or life-threatening risks of a drug.
However, analysts said a black box warning would not significantly affect the company’s sales.
One possible warning could tell doctors to give appropriate doses to patients suffering from moderate and severe liver impairment, Credit Suisse analyst Alethia Young said. Such a warning would not significantly hurt sales, Young added.
“All in all, it does not appear that this is serious enough to remove the drug from the market and at the most, Intercept spends more on medical education and gets a black box warning on the product insert,” said Liana Moussatos, an analyst at Wedbush Securities.
Ocaliva, approved last May, is used to treat primary biliary cholangitis (PBC), a rare, chronic liver disease that causes bile ducts in the liver to become inflamed, damaged and destroyed.
The FDA on Thursday warned about Ocaliva being incorrectly dosed in some patients with PBC, increasing the risk of liver injury and death.
Nineteen deaths and 11 cases of serious liver injury were associated with the use of Ocaliva, the FDA said.
Ocaliva accounted for nearly all of Intercept’s revenue of $30.9 million in the second quarter ended June 30.
The company’s shares, which had fallen 41 percent over the past two trading days, rose as much as 6.2 percent on Monday. The stock was slightly higher at $62.06 in afternoon trade.
Reporting by Manas Mishra in Bengaluru; Editing by Bernard Orr and Sai Sachin Ravikumar
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