Iqirvo

Opinion

EMA has issued an opinion on this medicine

Elafibranor

Overview

On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional¹ marketing authorisation for the medicinal product Iqirvo², intended for the treatment of primary biliary cholangitis (PBC).

The applicant for this medicinal product is Ipsen Pharma.

Iqirvo will be available as 80 mg film-coated tablets. The active substance of Iqirvo is elafibranor, a bile therapy (ATC code: A05AX06). Elafibranor and its main active metabolite, GFT1007, are dual peroxisome proliferator-activated receptor (PPAR) α/δ agonists. PPAR α/δ are thought to be key regulators of bile acid homeostasis, inflammation and fibrosis. Activation of PPARα and PPARδ decreases bile toxicity and improve cholestasis by modulating bile acid synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways.   

The benefits of Iqirvo are its ability to reduce alkaline phosphatase and bilirubin levels in adults with PBC. Iqirvo is therefore expected to have clinical benefits such as delayed development of liver fibrosis, cirrhosis, liver transplant and death. After authorisation, the company that markets Iqirvo must submit data on its efficacy in terms of clinically relevant events and safety. The most common side effects were abdominal pain, diarrhoea, nausea and vomiting.

The full indication is:

Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹ A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage

² This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Iqirvo

Reference Number: EMA/CHMP/327112/2024

Product details

• Name of medicine:
  Iqirvo
• Active substance:
  Elafibranor
• International non-proprietary name (INN) or common name:
  Elafibranor
• Therapeutic area (MeSH):
  Liver Cirrhosis, Biliary
• Anatomical therapeutic chemical (ATC) code:
  A05AX06
• EMA product number:
  EMEA/H/C/006231
• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Ipsen Pharma
• Opinion adopted:
  25/07/2024
• Opinion status:
  Positive