FDA Fast-Tracks Ipsen And Genfit's New Liver Disease Treatment, Iqirvo
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 11 2024
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Source: Benzinga
- Ipsen's FDA Approval for Iqirvo: Ipsen received accelerated approval from the FDA for Iqirvo (elafibranor) 80 mg tablets to treat primary biliary cholangitis (PBC).
- About PBC: PBC is a rare autoimmune liver disease causing bile build-up, toxins, inflammation, fibrosis, and bile duct damage.
- Iqirvo Details: Iqirvo is a first-in-class oral PPAR agonist, approved with or without UDCA, and was in-licensed from GENFIT S.A.
- Approval Basis and Study Results: The approval was based on ALP reduction; further trials are needed. A Phase III trial showed significant improvement with Iqirvo.
- Market Impact and Pricing: Iqirvo is now available in the U.S., offering a new PBC treatment option, priced at around $11,500 per month.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
