Ipsen's Iqirvo® Approved as First New Primary Biliary Cholangitis (PBC) Treatment in a Decade
Saturday, September 21, 2024
Ipsen has announced that the European Commission has conditionally approved Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in adults.
PBC primarily affects women and is characterised by the accumulation of bile and toxins in the liver, leading to chronic inflammation, scarring (fibrosis), and destruction of the bile ducts. If not managed effectively, the condition can lead to severe outcomes, including the need for liver transplantation.
The treatment is approved for use alongside ursodeoxycholic acid (UDCA) in patients who have not adequately responded to UDCA or as a monotherapy for those intolerant to UDCA.
Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist, targeting PPARα and PPARδ, which are key regulators of bile acid, inflammation, and fibrosis.
PBC is a rare autoimmune liver disease that predominantly affects women. Current treatments have limited effectiveness, with nearly half of patients not responding or being intolerant to existing therapies. Iqirvo provides a new treatment option for PBC patients, addressing disease progression and offering potential relief from symptoms such as pruritus (itching), a common and distressing symptom associated with the condition.
The approval is based on results from the Phase III ELATIVE 1 trial, which demonstrated a significant biochemical response in patients treated with Iqirvo. Data showed a 47% placebo-adjusted difference in response rates, with 51% of patients on Iqirvo achieving a positive outcome compared to just 4% in the placebo group.
Although a reduction in itching was observed, it was not statistically significant. The safety profile of Iqirvo was comparable to placebo, with similar rates of adverse events reported.
PBC is a progressive liver disease that, if untreated, can lead to liver failure, and in some cases, require transplantation. Iqirvo offers a promising new option for managing the disease, especially for patients experiencing severe symptoms or those at risk of disease progression.
An individualised approach to treatment is essential, as patients can present with varying symptoms and disease severity, making this approval a significant step forward for PBC care.
Source: globenewswire.com
