As with any medicine, the MHRA will keep the safety and
effectiveness of seladelpar under close review.
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.
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.
“We're 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.”
Seladelpar's 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.
