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Our Latest Update in ALS

Amylyx has started a process with the FDA and Health Canada to discontinue the marketing authorizations for RELYVRIO®/ALBRIOZA™ and remove the product from the market in the U.S. and Canada. As of April 4, 2024, RELYVRIO/ALBRIOZA is not available for new patients. As a result of this decision, RELYVRIO/ALBRIOZA/AMX0035 will no longer be available through an early access pathway in other countries where one was previously established for people living with ALS. Amylyx does not have any access programs in place at this time.  

Understanding Our Policy on Access Programs  

Our Commitment to People with Neurodegenerative Diseases

We understand the urgency faced by people living with neurodegenerative diseases. At Amylyx, it is our mission to one day end the suffering these relentlessly progressive diseases cause. 

 We believe the best way to get innovative medicines to the most people who may benefit requires two key elements:

  • Research: First is the conduct of research and development (R&D) in collaboration with the communities we serve and the experts in the field, that generates data demonstrating both the efficacy and safety of potential medicines.
  • Regulatory Action and Reimbursement: Second is moving through regulatory and reimbursement processes as quickly and efficiently as possible, following each country’s distinct pathways and timelines.  

With this in mind, we engage with the broader community, regulators, clinicians, and payers and reimbursement bodies early and often as we work to bring potential therapies to those who may benefit around the globe.  Under certain circumstances, we may be able to provide access to an investigational drug while it is still being studied in clinical trials.

For inquiries about our global access policy, please contact us at Medinfo@amylyx.com.

Use of Investigational Drugs

We collaborate with the broader neurodegenerative disease community, including people living with these diseases, clinicians, advocacy associations, and regulators to find the right time to provide access to our investigational drugs if appropriate.  

As we study our investigational drug in clinical trials, we may be allowed to provide it to some people with serious progressive neurodegenerative diseases to use, even if they are unable to participate in a clinical trial.

Specifically, in cases where clinical trial participation is not an option and a person has exhausted other available treatment options, the local regulatory agency may grant permission for Amylyx to provide a person access to an investigational drug prior to its approval.  

It is important to note that, by definition, investigational drugs have not received regulatory agency approval. Because of this, the full potential of their risks and benefits are not known. Doctors and interested individuals should consider all possible benefits and risks when seeking access to an investigational drug.

Amylyx does not plan to provide early access to an investigational drug outside of the diseases studied in clinical trials.

Amylyx Access Programs

At this time, there are no access programs available to initiate treatment with any Amylyx product in any of the neurodegenerative diseases in which they are being studied.  

Please contact medinfo@amylyx.com with additional questions.

Amylyx Clinical Trials

If you're interested in enrolling in an Amylyx clinical trial, speak with your physician to learn more.  Your physician can help you decide if a clinical trial is right for you. For more information about Amylyx clinical trials, visit www.clinicaltrials.gov.  For questions about our policy on access to investigational drugs, please contact us at: Medinfo@amylyx.com.  We reserve the right to update our policy at any time and will post any policy updates on this website as they become available.

Glossary

  • Clinical Trial: For a new drug to be approved for use, companies like Amylyx are required to conduct research studies to evaluate the safety and efficacy of their investigational drug and submit the results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those patients that meet the criteria of a clinical trial, participation comes with certain risks and these risks need to be discussed with your doctor.
  • Investigational Drug: A medicine that is being studied in a clinical trial. In most cases, investigational drugs may not be available to use outside of a clinical trial or other special authorization by a regulatory agency.

  • Access program: In cases where participation in a clinical trial is not an option and a person has exhausted other available treatment options, regulatory agencies may grant permission for Amylyx to provide access to an investigational drug prior to its approval. Regulatory agencies may also grant permission for Amylyx to provide access to a drug during the time after it has been approved but does not yet have governmental or commercial payment reimbursement.  

    This use of an investigational drug prior to regulatory agency approval or an approved drug prior to reimbursement may be referred to by a variety of names, such as early access, expanded access or compassionate use depending upon the naming convention used by a country’s regulatory agency. “Access program” is a catch all term inclusive of the different types of access pathways before regulatory approval and after regulatory approval before reimbursement is available.

  • Regulatory Agency or Regulators: A government organization that decides how and when an investigational drug can be studied, approved and made available for use or authorized for early access.
  • Regulatory Processes: The series of steps and reviews required by a Regulatory Agency to approve a drug for use.