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.
Intercept’s NASH Approval Timeline Shuffled Again With FDA Delay
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.
More from New Products
• By
The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.
• By
It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
More from Scrip
• By
It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.
• By
The German firm’s chairman, Hubertus von Baumbach, is adopting a ‘wait-and-see’ approach to the threat of pharma tariffs.
• By
Trump announced a 26% reciprocal tariff on India but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms and the US consumer are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?