Ipsen has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for its Elafibranor (Iqirvo) for the treatment of primary biliary cholangitis (PBC) in adults.
The product enhances liver performance, reducing bile acid production and diminishing liver inflammation.
The prescribed dose of Elafibranor is one tablet per day, taken consistently at the same time.
It can be administered alone or in conjunction with ursodeoxycholic acid (UDCA).
The MHRA’s endorsement follows a placebo-controlled study involving 161 adults with PBC, most of whom were on UDCA for more than a year and continued its use during the trial, although some ceased due to adverse effects.
Effectiveness was analysed by the reduction in blood levels of alkaline phosphatase (ALP) and bilirubin, both indicators of liver damage, to normal levels and by at least 15% for ALP after one year of treatment.
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51% of patients receiving Elafibranor experienced the requisite decrease in ALP and bilirubin levels, while only 4% of those on placebo did so.
Patients are advised to consult their healthcare providers if they encounter any side effects on receiving Elafibranor and to report such incidents through the MHRA’s Yellow Card scheme.
A progressive liver disease, PBC causes the bile ducts within the liver to become damaged, leading to bile accumulation and potential liver failure without treatment.
MHRA healthcare quality and access interim executive director Julian Beach stated: “Enabling safe access to high quality, safe and effective medicines is a key priority for us.
“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.”
