Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
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Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
The FDA has requested additional data from the company's clinical trial. Intercept's CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.
The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept's obeticholic acid.
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Intercept Pharmaceuticals and bluebird bio said they had encountered regulatory snags at the FDA for their investigational drugs, while Pfizer is pausing most of its clinical trials and delaying completion of a deal with Mylan to create a new company.
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In an interview at the BIO CEO & Investor Conference in New York Monday, CEO Pascal Prigent said barriers to access rather than reimbursement represent the biggest concern for NASH drugs like elafibranor. As a ballpark estimate, a list price in the $10,000 range is possible.
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The first FDA approval for a NASH drug, data on "off-the-shelf" CAR-T cells and a potential approval of a controversial drug for Alzheimer's disease are some of things in store for 2020.
While the FDA's scheduling an expert panel meeting for obeticholic acid after the original action date would delay its decision, an analyst wrote it would still likely be the first to win approval in NASH.
In a note to investors, an analyst wrote that the news bodes well for the company's anticipated Phase III readout for the drug, elafibranor. Another company, Intercept Pharmaceuticals, said the FDA had accepted its application for its investigational NASH drug, obeticholic acid.
The agency said it would likely require such drugs to undergo the traditional approval pathway, as there is insufficient evidence to support giving drugs accelerated approval based on surrogate endpoints.
The company's stock was nevertheless down more than 13 percent amid investor concerns about lack of intent-to-treat analysis on two-stage fibrosis improvement and gall stone events.