New treatment can help Canadians living with
hemophilia A better manage their bleeding episodes
TORONTO, July 12, 2019 /CNW/ - Novo Nordisk announced
today that Health Canada has approved ESPEROCT®
(Antihemophilic Factor VIII (Recombinant, B-Domain Truncated),
PEGylated) for use in adults and children with hemophilia A
(congenital Factor VIII deficiency) for:
- Routine prophylaxis to prevent or reduce the frequency of
bleeding episodes
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding.1
"Canadians living with hemophilia A are at risk of
bleeding for longer periods of time. If not treated
appropriately, those bleeding episodes, particularly into joints
and muscles, can be painful, lead to joint damage and muscular
atrophy over the patient's lifetime and in some cases can be life
threatening," said Dr. Anthony Chan,
OOnt, Professor of Paediatrics, McMaster
University. "ESPEROCT® has been shown to be
effective in reducing the risk of bleeding episodes among
patients."
Health Canada's approval is
based on the findings from three multinational, open-label,
non-controlled trials in male subjects with severe hemophilia A,
which is defined as having less than 1 per cent of the normal level
of factor VIII in the blood.2,3 All subjects were
previously treated, having received other FVIII products for more
than 150 exposure days for adolescents and adults and more than 50
exposure days for pediatric subjects.4
"The Canadian Hemophilia Society advocates for access to the
widest possible range of coagulation therapies and welcomes the
regulatory approval of this additional option for the treatment of
hemophilia A," said Paul Wilton,
President, Board of Directors, Canadian Hemophilia Society.
Overall, ESPEROCT® was shown to provide
effective prophylaxis and maintain a low median ABR of 1.18 when
dosed at 50 IU/kg every 3-4 days in adults and adolescents (those
aged 12 years and over) and a median ABR of 1.95 in children under
12 years of age when dosed twice weekly at 60 IU/kg (50-75
IU/kg).5
Across the clinical trials and age groups,
ESPEROCT® was well tolerated and had no safety
concerns identified.6 The safety profile of
ESPEROCT® is similar to what has been reported for
other long-action FVIII products.7
About Hemophilia A
Hemophilia A is an X-linked, recessive disorder caused by a
deficiency of functional plasma clotting factor VIII (FVIII), which
may be inherited or arise from spontaneous mutation.8
One out of three cases for the estimated 2,500 Canadians living
with hemophilia A are caused by a new genetic
mutation. 9,10 The most common symptom
associated with hemophilia is a bleeding problem, which can lower
the overall quality of life for many patients.11
About ESPEROCT®
ESPEROCT® (turoctocog alfa pegol, N8-GP) is an
extended half-life factor VIII molecule for replacement therapy in
people with hemophilia A. In adults, the half-life for
ESPEROCT® was determined to be 19 hours compared to 12
hours for unmodified FVIII products, using the chromogenic
assay.12
About Novo Nordisk
Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, hemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately
43,200 people in 79 countries, and markets its products in more
than 170 countries. For more information, visit novonordisk.ca,
Twitter and YouTube.
References:
________________________________
1 ESPEROCT®
Product Monograph, July 4, 2019
2 ESPEROCT® Product Monograph,
July 4, 2019
3 Canadian Hemophilia Society. What is hemophilia?
Available https://www.hemophilia.ca/what-is-hemophilia/. Accessed
on July 2, 2019.
4 ESPEROCT® Product Monograph,
July 4, 2019
5 ESPEROCT® Product Monograph,
July 4, 2019
6 ESPEROCT® Product Monograph,
July 4, 2019
7 ESPEROCT® Product Monograph,
July 4, 2019
8 Canadian Hemophilia Society. Hemophilia A and B.
Available https://www.hemophilia.ca/hemophilia-a-and-b/. Accessed
on June 27, 2019
9 Canadian Hemophilia Society. Hemophilia A and B.
Available https://www.hemophilia.ca/hemophilia-a-and-b/. Accessed
on June 27, 2019
10 Health Sciences North. Welcome to the Hemophilia
Program. Available
https://www.hsnsudbury.ca/portalen/Programs-and-Services/Community-Care-and-Rehabilitation/Hemophilia.
Accessed on June 27, 2019
11 Health Sciences North. Welcome to the Hemophilia
Program. Available
https://www.hsnsudbury.ca/portalen/Programs-and-Services/Community-Care-and-Rehabilitation/Hemophilia.
Accessed on June 27, 2019
12 ESPEROCT® Product Monograph,
July 4, 2019
SOURCE Novo Nordisk Canada Inc.