Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay

 
• By Joseph Haas
  
Generate a summary of this article
Listen to this article
Beta

The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.

Business time concept as a group of running businessmen and businesswomen using a giant clock to cross over a cliff as a bridge as a metaphor for schedule and appointment speed as a 3D illustration.
Intercept's timeline for OCA approval in NASH remains uncertain

The picture for Intercept Pharmaceuticals Inc.’s obeticholic acid (OCA) and the expected first approval of a drug for non-alcoholic steatohepatitis (NASH) grew hazier on 22 May when the company said a US Food and Drug Administration advisory committee review planned for 9 June has been postponed following the agency’s request for more data. Intercept said it will submit the information in the next week, but an approval decision for OCA likely will occur after the new drug application’s 26 June action date.

This is not the first delay on the road to approval for OCA – a farnesoid X receptor (FXR) agonist...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from New Products

Scrip-NewProducts (Premium-2): Top 12 Pharma Companies: Pfizer Tops The Leaderboard Again

 
• By Nabil

The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.

Innovent/GenFleet Score China’s First KRAS G12C Inhibitor Approval

 
• By Dexter Jie Yan

The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

Cagrisema Leads The Charge For 2025

 
• By Elizabeth Cairns

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Small But Mitey: Tarsus To Amp Up Strong Xdemvy Launch

 
• By Alexandra Shimmings

Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.    

More from Scrip

EHA: Lilly’s Jaypirca Posts First Phase III Triplet Win In CLL While BTK Degraders Advance - Clone

Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.

Top 10 Drugs Q1 2026: New Sheriff In Town As Mounjaro Unseats Keytruda

Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains