The Medicines and Healthcare products Regulatory Agency (MHRA)
has today 10 April 2026, approved olezarsen (Tryngolza)
to help treat adults with familial chylomicronemia syndrome
(FCS).
FCS is an inherited disease that gives rise to
abnormally high levels of fats called triglycerides in
the blood. This can lead to inflammation of the pancreas, causing
severe pain, lasting damage to the pancreas, and can be life
threatening.
Olezarsen is administered as an injection under the
skin, usually into the stomach area, the front of the thighs, or
the back of the upper arms.
In a main study involving 66 adults with
FCS, olezarsen was shown to significantly reduce
triglyceride levels in the blood. All patients followed a
controlled diet and received either Tryngolza or a
placebo.
After 6 months, patients treated with Tryngolza saw an
average reduction in triglycerides of 32%, compared with an
average increase of 12% in those given placebo. These benefits
were maintained and further improved after one year,
with fewer cases of acute pancreatitis reported in patients
taking Tryngolza.
Beach, Interim Executive Director
of Healthcare Quality and Access at the MHRA,
said:
“This approval provides a new treatment option for
adults living with
familial chylomicronemia syndrome, an inherited
condition that can lead to inflammation of the pancreas, causing
severe pain and potentially life-threatening complications.
“As with all medicines, we will continue to closely monitor the
safety and effectiveness of olezarsen as it is used
more widely.”
Notes to editors
-
The approval was granted on 10/04/2026 to Swedish
Orphan Biovitrum AB (publ)
-
This product was submitted and approved via IRP Route
B
-
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.
