|
The
decision came with certain conditions, including the release of
data from its global late-stage study of about 600 patients,
which is expected in 2024, as well as additional studies.
The approval for the drug, which will be sold in Canada under
the brand Albrioza, is based on a mid-stage study in 137
patients and a long-term follow-up phase, which showed it slowed
a decline in physical functioning among patients.
ALS, whose cause is largely unknown, causes nerve cells in the
brain and spinal cord to break down, affecting physical function
and resulting in severe disability and death.
About 3,000 Canadians are currently living with ALS, with the
average life expectancy from the symptom onset being two to five
years, according to the company.
Health Canada's approval comes ahead of a decision by the U.S.
Food and Drug Administration, which is expected by June 29.
A panel of outside advisers to the U.S. regulator had in March
voted 6-4 against approving the drug for ALS, AMX0035, saying
the clinical study data failed to establish it was effective
against the disease.
Commonly known as Lou Gehrig's disease, ALS entered the
spotlight in 2014 due to the "Ice Bucket Challenge", which
involved people filming themselves pouring ice-cold water over
their heads to raise awareness.
(Reporting by Leroy Leo in Bengaluru; Editing by Arun Koyyur)
[© 2022 Thomson Reuters. All rights
reserved.] Copyright 2022 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
|
|
