FDA okays Ipsen's Iqirvo as first PPAR agonistPPAR agonist for primary biliary cholangitis
2024-06-10
Ipsen on Monday secured an accelerated approval from the FDA for Iqirvo (elafibranor), making the oral PPAR agonistPPAR agonist the first new medicine cleared in the US for primary biliary cholangitis (PBC) in nearly a decade.
The filing, which was granted priority review, was based on positive data from the Phase III ELATIVE trial, published in the NEJM. The study demonstrated a 47% benefit with Iqirvo plus ursodeoxycholic acid (UDCA) on the composite primary endpoint, compared to placebo plus UDCA. Its main goal of cholestasis response was defined as alkaline phosphatase (ALP)
"For a significant number of people living with PBC, available treatments do not control the condition and may exacerbate symptoms of PBC. Left unmanaged, PBC can progress, leading to liver failure and in some cases, the need for a liver transplant… Iqirvo is therefore a much-needed treatment option," said Christelle Huguet, head of R&D at Ipsen.
The US label for Iqirvo calls for it to be given together with UDCA in adults who have an inadequate response to UDCA, or as monotherapy if they cannot tolerate UDCA. In 2021 Ipsen in-licensed the drug from Genfit, who now expects to receive €89 million ($95.8 million) in milestone payments this year.
Ipsen is not the only player in the race for effective PBC therapies. Seladelpar, a PPAR delta agonistPPAR delta agonist recently acquired by Gilead Sciences as part of its $4.3-billion takeout of CymaBay Therapeutics, is also under review at the FDA with an action date of August 14. Last week, Gilead shared additional long-term data on the drug, including steady improvement on the composite endpoint, as well as itch relief.
Key opinion leader (KOL) James Boyer recently weighed in on where PPAR agonistsPPAR agonists could fit into the treatment paradigm. In an interview with FirstWord, he suggested that patients needing alternative therapy after UDCA are typically put on Intercept Pharmaceuticals' Ocaliva (obeticholic acid), but those with elevated ALP levels or itching may switch to Iqirvo or seladelpar. Patients with elevated ALP after at least six months on UDCA will likely be treated with PPAR agonistsPPAR agonists instead of Ocaliva moving forward, he added.
For more on that interview, see – KOL Views Q&A: Leading expert sizes up PPAR battle between elafibranor, seladelpar in PBC.
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