In final draft guidance published
today (29 April 2026) NICE has
recommended rozanolixizumab as a new
treatment option on the NHS for some adults
with generalised myasthenia gravis
(gMG).
Generalised myasthenia gravis is a
rare, lifelong and debilitating autoimmune disease
that causes muscle weakness and extreme fatigue, affecting
breathing, speech, swallowing, vision and
mobility. Many people with the condition experience
unpredictable flare‑ups, repeated
hospital visits and a high treatment burden, with no
cure currently available.
Rozanolixizumab (also
called Rystiggo and made by UCB Pharma) can
be self-administered at home and will be
available to around 800 people across
England to help tackle symptoms and improve quality of
life.
It will be made available on the
NHS in
England immediately under interim
funding through the Innovative Medicines
Fund.
NICE has recommended
rozanolixumab for people who test positive for
anti-acetylcholine receptor (AChR) or anti-muscle-specific
tyrosine kinase (MuSK) antibodies and whose condition remains uncontrolled
despite them being on standard
treatment.
Rozanolixizumab becomes the first
NICE-recommended treatment for gMG and means
eligible patients in England will have access to an innovative,
targeted therapy that can reduce symptoms and
improve the ability to carry
out daily activities.
Clinical evidence shows that
adding rozanolixizumab to existing treatment can reduce
disease severity and improve patients' ability to carry out
everyday activities, compared with standard care alone. The
independent committee heard that even small improvements in
symptoms can make a meaningful difference
to the quality of life of people living with
the condition.
Helen Knight, director of
medicines evaluation at NICE,
said: “Generalised myasthenia gravis can have a profound
impact on people's lives, limiting their independence and placing
a significant burden not
only on patients, but on their families
and carers as well.
“Today's draft recommendation
marks an important step forward for people living
with the condition when
it remains uncontrolled on current
treatment. Rozanolixizumab offers a new targeted
treatment option with the potential
to improve symptoms and help people carry out
their day‑to‑day activities.”
Typically, people
with gMG that remains uncontrolled on
current treatment will have intravenous immunoglobulin
(IVIg) or plasma exchange (PLEX) or will try a different type of
immunosuppressant. IVIg and PLEX
both require regular hospital visits or
stays. Rozanolixizumab is given as a short course of
infusions under the skin and can be supported
through a homecare service, allowing many people to
self-administer treatment at home.
The committee heard this more
convenient approach can reduce disruption to work and family
life, lessen the burden on carers, and help improve mental
wellbeing for patients who
find hospital‑based treatment stressful or difficult to
access. They also heard that improved disease control may
also allow some patients to
reduce long‑term corticosteroid use, potentially lowering the
risk of steroid‑related side effects.
Today's final draft recommendation follows
agreement of an improved commercial arrangement between NHS
England and the company. NICE expects to publish
its final
guidance on rozanolixizumab next
month.
Ends
-
NICE's final draft guidance
on rozanolixizumab for
treating antibody-positive igeneralised myasthenia
gravis is available (from 00:01, Wednesday, 29
April) on the NICE website at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10994/documents
-
The draft guidance
recommends rozanolixizumab, as an add-on to standard
treatment, as an option to treat generalised
myasthenia gravis in adults who test positive for
anti-acetylcholine receptor (AChR) or anti-muscle-specific
tyrosine kinase (MuSK) antibodies. It can only be used
if:
-
the condition is classified as
Myasthenia Gravis Foundation of America (MGFA) class 2 to
4a
-
the condition is uncontrolled after
2 or more treatments, excluding acetylcholinesterase
inhibitors, and
-
intravenous immunoglobulin (IVIg) or
plasma exchange (PLEX) would otherwise be offered,
or has been tried and stopped because of side effects or
because it did not work well
enough.
