Europe - EC Decision for Ipsen's Iqirvo (elafibranor) CMA in PBC

Ipsen has announced that the European Commission has granted its Decision for the Conditional Marketing Authorisation (CMA) for Iqirvo (elafibranor) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA.

The approval  is based on data from the phase III ELATIVE trial, which demonstrated a statistically significant treatment benefit with a 47% placebo-adjusted difference (P<0.001) between patients on Iqirvo 80mg (51%) compared with patients on placebo (4%) achieving a biochemical response. A greater decrease in PBC Worst Itch-NRS score from baseline was also observed for patients on Iqirvo versus placebo, but this was not statistically significant.

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. Similar percentages of patients in the Iqirvo group and the placebo group experienced adverse events, treatment-related adverse events, severe or serious adverse events or adverse events leading to discontinuation.

As a reminder, Iqirvo was granted a positive Opinion by the CHMP in July 2024