French biopharmaceutical company Ipsen has received the European Commission’s (EC) conditional approval for Iqirvo (elafibranor) 80mg in combination with ursodeoxycholic acid (UDCA), to treat primary biliary cholangitis (PBC).
Iqirvo is an oral, peroxisome proliferator-activated receptor (PPAR) agonist, that works on PPARα and PPARδ proteins, which are believed to regulate bile acid, inflammation and fibrosis.
Iqirvo plus UDCA combination is indicated for the treatment of PBC in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.
In June this year, Ipsen received the US Food and Drug Administration (FDA) approval for Iqirvo plus UDCA, following the FDA Breakthrough Therapy Designation granted in 2019.
Ipsen chief medical officer Sandra Silvestri said: “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.
“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.”
The EC approval was based on data from the Phase 3 ELATIVE clinical trial, which evaluated the efficacy and safety of Iqirvo 80mg compared to placebo.
The study enrolled 161 patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid (UDCA), who were randomised 2:1 to receive either Iqirvo or placebo.
ELATIVE study showed a statistically significant treatment benefit, with 51% of patients on Iqirvo 80mg achieving a biochemical response compared to 4% with a placebo.
Patients on Iqirvo achieved a greater decrease in PBC Worst Itch-NRS score from baseline compared to placebo, which was not statistically significant.
Also, treatment with Iqirvo resulted in an improvement in pruritus (itch), based on a greater reduction in PBC-40 itch and 5-D itch total scores compared to placebo.
University of Milano-Bicocca professor of gastroenterology and consultant hepatologist at the Niguarda Liver Transplant Centre, Milan, Marco Carbone said: “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.
“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.”
