Ipsen has announced that the U.S. Food and Drug Administration has granted accelerated approval for Iqirvo® 80 mg tablets. This medication is for treating primary biliary cholangitis (PBC) and can be prescribed in combination with ursodeoxycholic acid (UDCA) for adults who do not respond adequately to UDCA or as a monotherapy for those intolerant to UDCA. Approval was based on reductions in alkaline phosphatase (ALP) levels, with continued approval contingent on verification of clinical benefits in ongoing confirmatory studies. Iqirvo is not suitable for patients with decompensated cirrhosis.

Christelle Huguet, Ipsen’s Executive Vice President and Director of Research and Development, highlighted Iqirvo’s importance, noting the significant need for effective PBC treatments. Iqirvo, a peroxisome proliferator-activated receptor (PPAR) agonist, is a new therapeutic option for PBC and the first new drug for the condition in nearly ten years. Approval followed data from the Phase III ELATIVE trial, which demonstrated substantial improvements in biochemical responses compared to UDCA alone.

In the ELATIVE trial, 51% of patients treated with Iqirvo and UDCA achieved the primary endpoint of biochemical response, compared to 4% in the placebo group. Additionally, 15% of patients on Iqirvo normalized their ALP levels, compared to none in the placebo group. Common side effects included weight gain, abdominal pain, diarrhea, nausea, and vomiting, while serious adverse events included myalgia, myopathy, rhabdomyolysis, fractures, fetal development issues, liver injury, hypersensitivity reactions, and bile duct obstruction.

Dr. Kris Kowdley, Director at the Liver Institute Northwest and lead investigator of the ELATIVE study, noted Iqirvo’s potential to significantly lower ALP levels in PBC patients. Carol Roberts, Executive Chairman of PBCers, emphasized the importance of new treatment options for PBC patients, who often feel misunderstood regarding their symptoms.

Applications for Iqirvo’s approval have also been submitted to the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, with decisions expected in the latter half of 2024. The FDA's approval strengthens Ipsen's portfolio of treatments for rare cholestatic liver diseases available in the US.

Iqirvo, an oral PPAR agonist, treats PBC in combination with UDCA or as monotherapy for UDCA-intolerant patients. It received Breakthrough Therapy designation from the FDA in 2019 and is under regulatory review by the EMA and MHRA. Ipsen acquired the rights to elafibranor from GENFIT in 2021. Iqirvo's approval is part of the FDA's Accelerated Approval Program, and a confirmatory trial, ELFIDENCE, is ongoing.

ELATIVE was a multicenter, double-blind, placebo-controlled trial evaluating Iqirvo's safety and efficacy. The trial included 161 patients, with most receiving Iqirvo or placebo in combination with UDCA. The trial showed a significant therapeutic benefit, with 51% of Iqirvo-treated patients achieving a biochemical response compared to 4% in the placebo group. The results, published in the New England Journal of Medicine, indicated rapid and sustained ALP reductions. Common adverse reactions included weight gain, abdominal pain, nausea, vomiting, and diarrhea.

 

Source: globenewswire.com

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