- ZILBRYSQTM (zilucoplan injection) is the first
and only self-administered C5 complement inhibitor indicated for
the treatment of generalized Myasthenia Gravis (gMG) in adult
patients who are anti-acetylcholine receptor (AChR) antibody
positive*.1
- Health Canada's approval is
supported by the pivotal Phase III RAISE study in gMG in adult
patients which demonstrated that treatment with ZILBRYSQ resulted
in statistically significant and clinically meaningful improvements
in gMG-specific efficacy outcomes.2
- The approval of ZILBRYSQ for adults with
anti-acetylcholine receptor (AChR) antibody positive gMG
demonstrates UCB's commitment to advancing science in severe
neurological and autoimmune diseases, addressing the gMG
community's unmet needs and improving clinical outcomes.
OAKVILLE, ON, July 17,
2024 /CNW/ - UCB Canada Inc. is pleased to announce
that ZILBRYSQTM (zilucoplan injection) received
authorization from Health Canada on July 11,
2024 for the treatment of generalized Myasthenia Gravis
(gMG) in adult patients who are anti-acetylcholine receptor (AChR)
antibody positive.* gMG is a rare, chronic autoimmune neuromuscular
condition that causes skeletal muscle weakness, affecting the
muscles of the eyes, face, neck, arms, legs, and throat. The onset
of symptoms is usually quick and there is no cure.3
![UCB Canada Inc. (CNW Group/UCB Canada Inc.) UCB Canada Inc. (CNW Group/UCB Canada Inc.)](https://mma.prnewswire.com/media/2462842/UCB_Canada_Inc__ZILBRYSQTM__zilucoplan_injection__Now_Approved_f.jpg)
ZILBRYSQ is a C5 inhibitor and inhibits complement-mediated
damage to the neuromuscular junction through its targeted dual
mechanism of action.2 Patients will be able to
administer the ZILBRYSQ injection at home using pre-filled
syringes. Benefits of subcutaneous self-injection can include
reduced traveling time to and from hospitals, decreased
interference with work obligations, and increased independence.
Unlike monoclonal antibody C5 inhibitors, as a peptide, ZILBRYSQ
can be used concomitantly with intravenous immunoglobulin and
plasma exchange, without the need for supplemental
dosing.2
"Health Canada's approval of
ZILBRYSQ marks a significant milestone for UCB Canada. As our first
step in supporting the gMG community in Canada, this achievement represents a
breakthrough in a new therapeutic area for our company," says
Rodrigo Reis, Country Lead, UCB
Canada. "Looking ahead, we are hopeful that we will have two
approved therapeutic solutions for gMG patients by the end of 2024.
Our focus remains on pioneering scientific solutions that elevate
the standard of care, enhancing the lives of those affected by gMG
and other rare diseases."
Health Canada approval of
ZILBRYSQ is based on UCB's RAISE study which demonstrated that
zilucoplan delivered rapid, consistent, statistically significant
and clinically meaningful benefits in different
patient-and-clinician-reported outcomes – Myasthenia
Gravis-Activities of Daily Living (MG-ADL) score, Quantitative
Myasthenia Gravis (QMG) score, Myasthenia Gravis Composite (MGC)
score and Myasthenia Gravis Quality of Life 15-item scale
(MG-QoL15r)** – at week 12 in a broad population of mild to severe
adult patients with AChR antibody positive gMG.2
"Until now, Canadians living with gMG have only had access to C5
therapy intravenously, which can be time-consuming and burdensome
for the health care system," explained Dr. Angela Genge, Medical Director, Clinical
Research Unit (CRU), Montreal Neurological Institute and
international leader in clinical trial design and development for
rare neurological conditions. "Health Canada's approval of the first once-daily and
only self-administered C5 complement inhibitor that provides
significant and clinically meaningful improvements addresses a
great unmet need by providing people living with this
often-debilitating rare disease with choice and
flexibility."
"Generalized myasthenia gravis can profoundly impact a person's
physical, emotional, social, and financial well-being. The
unpredictable and fluctuating symptoms can be debilitating,
significantly affecting patients' day-to-day lives," said
Stacey Lintern, Chief Executive
Officer, Muscular Dystrophy Canada. "The gMG community in
Canada has long awaited new
treatment options that extend beyond symptom-management and offer
the potential to improve outcomes and reduce burden. Today's
announcement brings new hope for people with gMG, introducing a
treatment option that promises to enhance the quality of life for
many Canadians. This progress marks a significant step forward in
the ongoing need for improved and accessible treatment options for
gMG, offering renewed optimism for patients and their
families."
UCB Canada anticipates supply availability of ZILBRYSQ in Q4
2024.
About Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG) is a rare chronic, autoimmune
neuromuscular disease characterized by muscle weakness that worsens
after periods of activity and improves after periods of rest. gMG
can affect people of all races, ages and genders but is not thought
to be directly inherited, nor is it contagious.4,5
Approximately 32 out of every 100,000 people are living with
gMG6 and it affects each person differently. Common
symptoms include chronic fatigue and weakness in different muscle
groups, that can impact daily activities – such as tooth-brushing,
hair-combing, speaking (dysarthria) or swallowing (dysphagia) – and
quality of life. In addition, symptom severity can increase
unexpectedly, and might lead to hospitalization.5
gMG can have a significant economic impact on those living with
it, with loss of income and lack of funds for emergency care cited
as particularly challenging.7 The condition is
associated with substantial healthcare costs and resource use, with
hospitalization being the most significant factor.8
About the RAISE Study
The RAISE study (NCT04115293)
was a multi-centre, Phase III, randomized, double-blind,
placebo-controlled study to confirm the efficacy, safety, and
tolerability of zilucoplan in adult patients with
anti-acetylcholine receptor (AChR) antibody positive gMG. Patients
were randomized in a 1:1 ratio to receive once daily subcutaneous
injection of 0.3 mg/kg zilucoplan or placebo for 12 weeks.
The primary endpoint for the RAISE study was change from
baseline to Week 12 in the Myasthenia Gravis-Activities of Daily
Living (MG-ADL) score. Secondary endpoints included change from
baseline in the Quantitative Myasthenia Gravis (QMG) score, the
Myasthenia Gravis Composite (MGC) and the Myasthenia Gravis Quality
of Life 15 revised (MG-QoL15r) score from baseline to Week 12, time
to first rescue therapy, the proportion of patients with minimal
symptom expression (MSE) (defined as MG-ADL of 0 or 1 without
rescue therapy), the proportion with a ≥3-point reduction in MG-ADL
without rescue therapy and the proportion with a ≥5-point reduction
in QMG without rescue therapy, all measured at Week 12. Safety was
assessed by the incidence of treatment emergent adverse events
(TEAEs). Patients who completed the RAISE trial had the possibility
to enter the open-label extension study, RAISE-XT
(NCT04225871).2
More information about ZILBRYSQ can be found by accessing the
product monograph.
About UCB Canada Inc.
Inspired by patients and driven
by science, UCB Canada Inc. is a biopharmaceutical company focused
on the discovery and development of innovative medicines and
solutions to transform the lives of people living with severe
autoimmune and central nervous system diseases. For more
information, please consult https://www.ucb-canada.ca/.
About UCB
UCB, Brussels, Belgium
(www.ucb.com) is a global biopharmaceutical company focused on the
discovery and development of innovative medicines and solutions to
transform the lives of people living with severe diseases of the
immune system or of the central nervous system. With approximately
8,400 people in nearly 40 countries, the company generated revenue
of €5.3 billion in 2020. UCB is listed on Euronext Brussels
(symbol: UCB). Follow us on Twitter: @UCB_news.
* Patients continued to receive standard therapy throughout the
pivotal trial.
**The threshold for clinical meaningfulness for MG-QoL 15r has not
be established.
References
________________________________
|
1 ZILBRYSQ Product Monograph,
2024.
|
2
Howard JF Jr et al. Safety and efficacy of zilucoplan in
patients with generalised myasthenia gravis (RAISE): a randomised,
double-blind, placebo-controlled, phase study. Lancet Neurol.
2023;22:395-406.
|
3 Cleveland
Clinic. Myasthenia Gravis (MG), Myasthenia Gravis: What It Is,
Causes, Symptoms & Treatment (clevelandclinic.org). Accessed
May 2024.
|
4 National
Institute of Neurological Disorders and Stroke. What is
Myasthenia Gravis. www.ninds.nih.gov/health-information/disorders/myasthenia-gravis.
Accessed May 2024.
|
5 Muscular
Dystrophy Canada. Myasthenia Gravis: Know All About It.
ALE19SO021024_PSPMGDiseasesBrochure_E7_v2.pdf (muscle.ca). Accessed
May 2024.
|
6 Bubuioc, A. M., Kudebayeva, A.,
Turuspekova, S., Lisnic, V., & Leone, M. A. (2021). The
epidemiology of myasthenia gravis. Journal of medicine and life,
14(1), 7–16.
https://doi.org/10.25122/jml-2020-0145.
|
7 Hughes
Tom et al. The economic burden of individuals living with
generalized myasthenia gravis and facing social determinants of
health challenges. Front Public Health. 2023 Sep 12:11:1247931.
https://pubmed.ncbi.nlm.nih.gov/37766748/. Accessed June
2024.
|
8 Zhdanava, M et al. Economic burden
of generalized myasthenia gravis (MG) in the United States and the
impact of common comorbidities and acute MG-events. Current Medical
Research and Opinion, 1–9.
www.tandfonline.com/doi/full/10.1080/03007995.2024.2353381.
Accessed June 2024.
|
SOURCE UCB Canada Inc.