The European Commission has conditionally approved Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA).

The approval is limited to adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.

Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist, that exerts an effect on the proteins PPARα and PPARδ, thought to be key regulators of bile acid, inflammation and fibrosis.

“We are delighted that Iqirvo is approved in the EU as an effective new option for the treatment of people living with PBC. This is a rare liver disease, predominantly found in women, which hasn’t seen new innovation for nearly a decade. This is despite up to half of patients being intolerant or unresponsive to current therapies,” said Sandra Silvestri, Chief Medical Officer, Ipsen. “For those patients with PBC that may be at risk of disease progression and who continue to suffer from debilitating symptoms of the disease, we are delighted to be able to offer an effective treatment choice.”

Positive news for PBC patients

The approval was based on data from the Phase III ELATIVE trial, which demonstrated a statistically significant treatment benefit with a 47% placebo-adjusted difference between patients on Iqirvo 80mg (51%) compared with patients on placebo (4%) achieving a biochemical response.

Treatment with Iqirvo was associated with an improvement in pruritus (itch) as evidenced by a greater reduction in PBC-40 itch and 5-D itch total scores compared to placebo.

“It is a positive development in the treatment and management of PBC that we have a new, efficacious and well-tolerated treatment for our patients living with the condition,” said Dr Marco Carbone, Professor of Gastroenterology, University of Milano-Bicocca and Consultant Hepatologist, the Niguarda Liver Transplant Centre, Milan. “PBC is a progressive liver disease that can lead to liver failure and in some people the need for liver transplantation. So, this new medicine, that has demonstrated its potential in managing disease progression, as well as reducing itch, a symptom that can have a detrimental effect on patients’ quality of life, is positive news for doctors and their patients.”

Diana Spencer, Senior Digital Content Editor, DDW