Amylyx Pharmaceuticals recently announced that Canada has approved ‘Albrioza’, its treatment for neurodegenerative disease amyotrophic lateral sclerosis (ALS). This is considered to be the first certification for oral medicine given by Canada.
The combination of orally active chemicals sodium phenylbutyrate and taurursodiol known as Albrioza has been approved in Canada for the first time, signaling Amylyx's transition from advancement to a commercial-stage business.
The decision was based on the data released during a global late-stage study involving around 600 patients, by 2024, as well as the completion of subsequent investigations. The drug's approval appears to be based on mid-stage research among 137 patients and a long-term follow-up period that demonstrated it reduced the deterioration in physical functioning among the participants.
The cause of ALS is unknown, but studies cite that it causes nerve impulses in the spinal cord and the brain to break down, further impairing physical function and eventually leading to death. According to Amylyx, around 3,000 Canadians are living with ALS, with an average life expectancy of two to five years after the onset of symptoms.
The company declared that Albrioza will be available in Canada within the next six weeks and that it will collaborate on access with the pan-Canadian Pharmaceutical Alliance, which undertakes price negotiations with manufacturers for government drug programs, as well as the federal, provincial, and territorial governments.
According to Tammy Moore, chief executive of the ALS Society of Canada, ALS is a deadly disease that can strike at any time. It's vital that all Canadians, regardless of where they live, benefit from such innovative medicines and other upcoming advances as soon as possible after regulatory approval. As she believes more time wasted will increase its severity and cause a high death rate.
ALS, also known as Lou Gehrig's disease, sprang to prominence in 2014 because of the "Ice Bucket Challenge," in which individuals filmed themselves spilling ice-cold water over their heads to promote awareness.
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https://financialpost.com/pmn/business-pmn/amylyx-gets-first-approval-for-als-drug-from-canada