Health Canada has granted approval for Amylyx Pharmaceuticals’ Albrioza (sodium phenylbutyrate and ursodoxicoltaurine, AMX0035), with conditions, to treat amyotrophic lateral sclerosis (ALS)

An oral fixed-dose combination therapy, Albrioza is claimed to lower neuronal cell death, hypothesised to happen by mitigating endoplasmic reticulum (ER) stress and mitochondrial dysfunction at the same time. 

The latest development marks the first marketing approval for Albrioza.

According to clinical findings, ALS patients who received Albrioza, either as a stand-alone treatment or along with current ALS therapies, had a statistically significant and clinically meaningful benefit in functional outcomes versus placebo.

The regulatory agency authorised the approval of Albrioza under the Notice of Compliance with Conditions policy. 

One of the approval conditions is the submission of findings from the ongoing placebo-controlled, randomised Phase III PHOENIX trial of AMX0035 while further or ongoing studies are included as other conditions. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Topline results from the PHOENIX trial are anticipated in 2024.

The latest approval is based on findings from a multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

The trial had a six-month, randomised placebo-controlled phase and an open-label long-term follow-up phase.

Data showed that Albrioza-treated subjects scored, on average, 2.32 points better on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) over a 24-week duration. 

Amylyx Pharmaceuticals Canada general manager and head Chris Aiello said: “We anticipate that Albrioza will be available commercially in Canada within the next six weeks. 

“We are prepared to work with the pan-Canadian Pharmaceutical Alliance (pCPA) and federal, provincial and territorial governments to negotiate the listing of Albrioza expeditiously so that eligible Canadians living with ALS can obtain access as quickly and efficiently as possible.”