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In response, the company has decided to discontinue all NASH-related investment.
Intercept first sought FDA approval for OCA in treatment of NASH in 2019 and received a complete response letter. The company refiled for a new drug application in December 2022. A second resubmission would require a completion of the long-term outcomes phase of an ongoing clinical trial, according to an Intercept press release.
The FDA decision follows the recommendation from May’s FDA Gastrointestinal Drugs Advisory Committee meeting. During the meeting, members voted 15 to 1 to advise deferring approval until clinical outcome data became available. Intercept’s clinical trial data demonstrated that OCA showed moderate benefit over placebo in improving fibrosis in NASH patients, but “there is uncertainty how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes,” an FDA meeting briefing document stated. There were also notable safety concerns including an increased risk for drug-induced liver injury.
An estimated 16.8 million Americans have NASH, and there are no FDA-approved medications for the condition.
Intercept plans to promptly begin closing out their NASH clinical trial and restructuring to focus on rare and serious liver diseases.
“While this is clearly not the outcome that we have worked toward, I’m proud of the impact that Intercept has made to move the science of NASH forward and bring the field closer to a treatment option,” said Jerry Durso, the president and CEO of Intercept, in a statement. “Intercept thanks the scientists, clinicians, and patients whose contributions to the clinical development of OCA in NASH have significantly advanced the understanding of this deadly disease.”
A version of this article originally appeared on Medscape.com.
In response, the company has decided to discontinue all NASH-related investment.
Intercept first sought FDA approval for OCA in treatment of NASH in 2019 and received a complete response letter. The company refiled for a new drug application in December 2022. A second resubmission would require a completion of the long-term outcomes phase of an ongoing clinical trial, according to an Intercept press release.
The FDA decision follows the recommendation from May’s FDA Gastrointestinal Drugs Advisory Committee meeting. During the meeting, members voted 15 to 1 to advise deferring approval until clinical outcome data became available. Intercept’s clinical trial data demonstrated that OCA showed moderate benefit over placebo in improving fibrosis in NASH patients, but “there is uncertainty how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes,” an FDA meeting briefing document stated. There were also notable safety concerns including an increased risk for drug-induced liver injury.
An estimated 16.8 million Americans have NASH, and there are no FDA-approved medications for the condition.
Intercept plans to promptly begin closing out their NASH clinical trial and restructuring to focus on rare and serious liver diseases.
“While this is clearly not the outcome that we have worked toward, I’m proud of the impact that Intercept has made to move the science of NASH forward and bring the field closer to a treatment option,” said Jerry Durso, the president and CEO of Intercept, in a statement. “Intercept thanks the scientists, clinicians, and patients whose contributions to the clinical development of OCA in NASH have significantly advanced the understanding of this deadly disease.”
A version of this article originally appeared on Medscape.com.
In response, the company has decided to discontinue all NASH-related investment.
Intercept first sought FDA approval for OCA in treatment of NASH in 2019 and received a complete response letter. The company refiled for a new drug application in December 2022. A second resubmission would require a completion of the long-term outcomes phase of an ongoing clinical trial, according to an Intercept press release.
The FDA decision follows the recommendation from May’s FDA Gastrointestinal Drugs Advisory Committee meeting. During the meeting, members voted 15 to 1 to advise deferring approval until clinical outcome data became available. Intercept’s clinical trial data demonstrated that OCA showed moderate benefit over placebo in improving fibrosis in NASH patients, but “there is uncertainty how the magnitude of changes in these surrogate endpoints may translate to meaningful changes in clinical outcomes,” an FDA meeting briefing document stated. There were also notable safety concerns including an increased risk for drug-induced liver injury.
An estimated 16.8 million Americans have NASH, and there are no FDA-approved medications for the condition.
Intercept plans to promptly begin closing out their NASH clinical trial and restructuring to focus on rare and serious liver diseases.
“While this is clearly not the outcome that we have worked toward, I’m proud of the impact that Intercept has made to move the science of NASH forward and bring the field closer to a treatment option,” said Jerry Durso, the president and CEO of Intercept, in a statement. “Intercept thanks the scientists, clinicians, and patients whose contributions to the clinical development of OCA in NASH have significantly advanced the understanding of this deadly disease.”
A version of this article originally appeared on Medscape.com.