A pivotal moment for NASH nears

Six years ago at JPM, Intercept Pharmaceuticals had investors (and journalists) scrambling to Google to look up the definition of NASH after the surprising and positive results from a mid-stage clinical trial sent the biotech’s stock price soaring. It’s been a long and bumpy road since January 2014, but Intercept’s NASH drug — the biotech industry’s first — is finally on the cusp of a highly anticipated commercial launch later this year.

But first, Intercept needs to secure the NASH drug’s approval. Step one in that process will be an FDA advisory panel tentatively scheduled for April 22.

“It’s difficult from the outside to appreciate this but preparation for these FDA advisory panels is actually more work than the New Drug Application itself,” Intercept CEO Mark Pruzanski said in an interview with STAT’s Adam Feuerstein on Tuesday. “You really need to do deep dives across each and every possible topic that may come up, and of course there is very little visibility on what those topics might be.”

Adam will have more details about Intercept’s NASH drug plans from the Pruzanski interview later today at statnews.com.