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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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.
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.
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.
Shares of the New York-based company jumped nearly 20 percent Tuesday on news that the REGENERATE study of obeticholic acid showed strong improvement in NASH-related liver fibrosis.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.