GovWire

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16 January 2025, approved the medicine seladelpar (Livdelzi) in adults for the treatment of a liver illness called Primary Biliary Cholangitis (PBC), including pruritus. It works by controlling liver problems in the body and making the liver less inflamed

Seladelpar belongs to a group of medicines called peroxisome proliferator-activated receptor delta agonists. The medicine can only be prescribed to adult patients with PBC, including pruritus, in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:

Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.

Were assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.

Seladelpars recommended dosage is one capsule (10 mg) once daily. The efficacy of seladelpar was primarily demonstrated in patients during a 12-month trial, where the medicine was studied in patients with PBC who had an inadequate response or intolerance to UDCA.

As with any medicine, the MHRA will keep the safety and effectiveness of seladelpar under close review.? Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors?

• The new marketing authorisation was granted on 16 January 2025 to CYMABAY IRELAND LIMITED.

• More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the?MHRA Products website?within 7 days of approval.??

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.??

• The MHRA is an executive agency of the Department of Health and Social Care.??

• For media enquiries, please contact the?newscentre@mhra.gov.uk, or call on 0

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