19 Patients Have Died While Using This New Liver Disease Drug, Some When Prescribed Higher-Than-Recommended Doses
(Posted by Tom Lamb at DrugInjuryWatch.com)
UPDATE: "FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease"
Intercept Pharmaceuticals Inc's Ocaliva (obeticholic acid) was approved by the FDA in May 2016 for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
While this relatively new liver disease medication has not been widely prescribed yet, there are expectations it could become a very significant drug product for Intercept.
From this September 21, 2017 article, "FDA Warns Doctors After 19 Deaths on Intercept Liver Drug", by reporter Robert Langreth, we get the following sales-related information:
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.
This liver side effects issue for Ocaliva was presented in this document, "FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease", issued on September 21, 2017.
From the Safety Announcement part of that document:
The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) 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. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose.... [emphasis added]
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To put this development into context, we turn to journalist Tracy Staton's September 22, 2017 report, "FDA flags 19 deaths in Ocaliva patients, putting Intercept's NASH bid in doubt". From her piece we get this looking-forward information:
The deaths and injuries could lead to a black-box warning, the FDA’s most severe, and that would likely affect Ocaliva’s current sales. That possibility “bears close watching, given the deleterious impact this could have on Intercept revenues now and in the future,” Leerink analyst Joseph Schwartz said in a note Thursday afternoon, adding, “This could significantly constrain the market opportunity for Ocaliva in PBC.”
But the bigger hit would come from a denied approval in NASH—nonalcoholic steatohepatitis—which is also known as fatty liver disease. A hit worth up to $7 billion, in fact. Analysts have predicted up to $8.6 billion in Ocaliva sales if it moves into the NASH market, and predictions run to $1.6 billion with just PBC on the label.
The dosing issue could raise a red flag with the FDA when that approval decision rolls around, because higher doses of Ocaliva would be on tap for NASH treatment. Also, PBC is an orphan indication. NASH isn’t, and myriad other drugs are moving toward an approval in that disease, though some have reported setbacks of their own....
In their Ocaliva Drug Safety Communication the FDA said patient should contact their doctors if they develop any of the following symptoms that may be signs of liver injury:
New or worsening fatigue
Nausea and vomiting
Change in behavior or confusion
Vague symptoms such as anxiety or unease
Yellow eyes or skin
We will continue to monitor the safety profile of Ocaliva and watch for any drug label revisions, such as a black-box warning, which may be mandated by the FDA.
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