NICE has today (Tuesday, 22 October)
recommended a new daily pill for people with a type of chronic
liver disease.
Elafibranor, also known as Iqirvo and
made by Ipsen Limited, is recommended in final draft guidance as
an option for treating adults with a rare type of liver disease
known as primary biliary cholangitis
(PBC).
It is recommended in combination with
ursodeoxycholic acid (UDCA), if the disease has not responded
well enough to UDCA, or alone, if UDCA cannot be
tolerated.
It is estimated that around 3,600
people in England could benefit from this new treatment
option.
PBC is a type of chronic liver disease
where the small bile ducts in the liver become damaged and
inflamed and are eventually destroyed. This can lead to a
build-up of bile and eventually cause liver damage and liver
failure if it is left untreated.
The dosage of elafibranor is one
tablet, taken once a day, at about the same time each day.
Elafibranor helps to improve liver
performance by reducing bile acid production and liver
inflammation.
Clinical trials showed that, after one
year, more people who have elafibranor have normal results for
some liver function tests than people who have
placebo.
There are around 25,000 people living
with PBC in the UK. Around 90% of the people who have PBC are
women, and around 25% of people with PBC are 40 years of age or
under.
NICE's final draft guidance for
elafibranor has been published just over two weeks after the
treatment was granted its marketing authorisation by the MHRA,
demonstrating NICE's commitment to getting the best care to
patients fast.
Interim funding for elafibranor has
been made available through the Innovative Medicines Fund (IMF),
meaning this treatment can be made available in the NHS from
today.
The company has a confidential
commercial arrangement through a simple discount patient access
scheme which makes elafibranor available to the NHS with a
discount.
Read the full final draft guidance for
elafibranor for treating primary biliary cholangitis on
the NICE
website.
