New Data Highlights IQIRVO®'s Efficacy in Treating Primary Biliary Cholangitis Symptoms
New late-breaking data reinforces IQIRVO®'s impact on ALP, fatigue and pruritus in PBC
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Recent data presented at the EASL congress reveals that IQIRVO® significantly reduces alkaline phosphatase (ALP) levels and improves fatigue and pruritus in patients with primary biliary cholangitis (PBC). In a real-world analysis, 59% of patients achieved ALP normalization, while 67% reported meaningful fatigue improvements after 52 weeks of treatment.
- 01IQIRVO® led to a significant ALP reduction, with 59% of patients achieving normalization at 6 months.
- 0267% of patients with moderate-to-severe fatigue experienced clinically meaningful fatigue improvements compared to 31% on placebo.
- 03In the U.S. real-world analysis, 72% of patients showed a ≥15% ALP reduction.
- 04The interim analysis from the ELFINITY Phase IV study indicated that 55% of patients achieved biochemical response within three months.
- 05IQIRVO® is the first approved PPAR agonist for PBC, addressing both disease biology and symptom burden.
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Ipsen recently presented new late-breaking data at the European Association for the Study of the Liver (EASL) congress, reinforcing the effectiveness of IQIRVO® (elafibranor) in treating primary biliary cholangitis (PBC). The data from the ELATIVE Phase III trial and two real-world studies demonstrate significant reductions in alkaline phosphatase (ALP) levels, with 59% of patients achieving normalization at 6 months. Furthermore, a post hoc analysis revealed that 67% of patients with moderate-to-severe fatigue reported meaningful improvements compared to 31% on placebo, with benefits observed as early as Week 4. The U.S. real-world analysis showed that 72% of patients experienced a ≥15% reduction in ALP. Additionally, interim results from the ELFINITY Phase IV study indicated that 55% of patients achieved biochemical response within three months. IQIRVO® is recognized as a significant advancement in PBC treatment, addressing both biochemical markers and debilitating symptoms such as fatigue and pruritus.
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The data indicates that IQIRVO® can significantly improve the quality of life for patients suffering from PBC by alleviating debilitating symptoms and improving liver function.
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