Intercept Pharmaceuticals Inc (NASDAQ: ICPT) is having an overwhelmingly strong day in the market today, and for good reason. The company announced prescription information surrounding Ocaliva(R). Today, we’ll talk about the information that was released, what we’re seeing from ICPT as a result, and what we’ll be watching for with regard to the stock ahead.
ICPT Gains On Prescription Data
As mentioned above, Intercept Pharmaceuticals is having an incredibly strong start day in the market today after announcing prescription data surrounding Ocaliva in the United States. In the announcement, the company said that prescribing information in the United States has been updated to reinforce appropriate dosing in primary biliary cholangitis (PBC) patients with Child-Pugh Class B or C or decompensated cirrhosis.
In the release, ICPT said that, in the post-marketing setting, hepatic decompensation and failure have been reported in patients with advanced cirrhosis when Ocaliva was dosed more frequently than recommended for a starting dose. In order to combat this issue, the Ocaliva label has been revised. The new label includes a boxed warning and a dosing table that reinforce the existing dosing schedule for such patients. These patients comprise about two to three percent of the overall PBC population. In a statement, Mark Pruzanski, M.D., President and CEO at ICPT, had the following to offer:
Following extensive review of postmarketing data, we remain confident in Ocaliva’s safety profile and the benefit it provides when used as directed in patients with PBC, a devastating disease that is one of the leading causes of liver failure in women… The focus of our label update is to aid physicians in identifying and appropriately dosing Ocaliva in the most vulnerable PBC patients with advanced cirrhosis.
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