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Gwen, living with ALS

Why RELYVRIO

I’M FIGHTING BACK

Take on ALS with RELYVRIO®

Gwen is living with ALS

Gwen is fighting back against ALS in every way she can. And not just for herself, but for others too. She is a passionate  advocate, pushing to reform public policy so people can have greater access to therapies.

A way to help fight ALS

RELYVRIO is a prescription oral therapy for adults living with ALS shown to help slow disease progression.

If prescribed by your doctor, RELYVRIO can be taken alone or with certain other FDA-approved treatments for ALS. Before taking any additional medications, talk to your doctor.

A chance to extend functional independence

RELYVRIO may help you maintain physical function longer so that you may continue to do the things you enjoy.

Slow DISEASE progression

The results from the CENTAUR clinical trial showed that RELYVRIO gave participants a chance to extend their functional independence by slowing the progression of ALS.

POINTS HIGHER THAN THE 
PLACEBO GROUP, ON AVERAGE

on the ALSFRS-R after 6 months of treatment.

Individual results may vary.

AVERAGE ALSFRS-R
SCORE AT 6 MONTHS

Chart showing CENTAUR clinical trial average ALSFRS-R score at 6 months on placebo and RELYVRIO

POINTS HIGHER THAN THE 
PLACEBO GROUP, ON AVERAGE

on the ALSFRS-R after 6 months of treatment.

Individual results may vary.

Gwen, living with ALS, getting help to stand up from her walker

Gwen, living with ALS, getting help to stand up from her walker

What is the ALSFRS-R score?

Respiratory function on the ALSFRS-R scale

RESPIRATORY

12 Points

Bulbar function on the ALSFRS-R scale

BULBAR

12 Points

Gross motor function on the ALSFRS-R scale

GROSS MOTOR

12 Points

Fine motor function on the ALSFRS-R scale

FINE MOTOR

12 Points

48 Points

WHAT DO 2 TO 3 POINTS REALLY MEAN?

A 2- to 3-point higher score could mean having a greater ability to breathe, speak, and walk, which may impact the ability to live more independently.

While ALS affects everyone differently, 2 points could make a big difference in someone’s life. It could mean:

  • Maintaining the ability to walk down the street while holding hands with your partner
  • Continuing to be able to talk on the phone and catch up with your favorite nephew
  • Maintaining your ability to physically stand up and speak clearly as an ALS advocate

How RELYVRIO was studied

CENTAUR Clinical Trial Logo

THE CENTAUR CLINICAL TRIAL FOR RELYVRIO

RELYVRIO was studied in the CENTAUR clinical trial, which had 2 phases:

1

Randomized phase (vs placebo)

  • 6 months
  • 137 randomized participants (89 took RELYVRIO, 48 placebo)
  • Participants also took certain other FDA-approved ALS therapies (71% took riluzole and 34% took edaravone)

MAIN GOAL: Study the safety and if RELYVRIO has an impact on slowing the rate of disease progression in ALS*

2

Open-label extension phase (all treated with RELYVRIO)

  • Up to ~35 months
  • 90 participants (56 continued on RELYVRIO and 34 started on RELYVRIO from the CENTAUR trial)
  • Participants were able to continue with certain other FDA-approved ALS therapies

MAIN GOAL: Study long-term safety of RELYVRIO

*As measured by the rate of decline in ALSFRS-R total score from start of trial through 6 months.

An exploratory analysis of survival

After the CENTAUR clinical trial was completed, a “post hoc” exploratory survival analysis observed that participants originally randomized to RELYVRIO saw a 4.8-month longer median overall survival compared with participants originally randomized to placebo group.

This exploratory analysis should be interpreted cautiously given limitations.

LIMITATIONS OF THE ANALYSIS

Some of the survival data analyzed included participants who were no longer being followed as closely as in the randomized phase of the clinical trial.

Some of these participants may have had procedures or taken therapies that may have impacted survival and were not included in the analysis, which could make the results for RELYVRIO appear better or worse than they actually are. Some examples include:

  • Tracheostomy
  • Starting permanent assisted ventilation
  • Starting or stopping other FDA-approved therapies for ALS
Doctor Discussion Guide Resource

WONDERING IF RELYVRIO COULD BE RIGHT FOR YOU?

Download a doctor discussion guide to keep track of questions you want to ask and notes you take during the appointment.

Doctor Discussion Guide Resource
Doctor Discussion Guide
Gwen, living with ALS

Generally well-tolerated

RELYVRIO WAS GENERALLY WELL-TOLERATED

In the CENTAUR clinical trial for RELYVRIO, the most common side effects were:

  • Diarrhea
  • Abdominal pain
  • Nausea
  • Upper respiratory tract infection

Gastrointestinal (GI) side effects occurred throughout the study but were more frequent during the first 3 weeks of treatment.

ADVERSE REACTIONS REPORTED IN MORE THAN 5% OF RELYVRIO-TREATED PARTICIPANTS WITH ALS AND AT LEAST 5% GREATER THAN PLACEBO (CENTAUR)

Adverse Reaction

RELYVRIO

n=89

(%)

PLACEBO

n=48

(%)

Diarrhea*

25

19

Abdominal pain*

21

13

Nausea

18

13

Upper respiratory tract infection*

18

10

Fatigue*

12

6

Salivary hypersecretion (drooling)

11

2

Dizziness

10

4

*Adverse reaction is composed of several similar terms.

GI Side Effect Resource

WHAT IF GI SIDE EFFECTS OCCUR?

Download this resource to learn more about experiencing and managing them.

GI Side Effect Resource
GI Side Effects
Gwen, living with ALS

I STILL HAVE
MORE TO DO

Learn what to expect from RELYVRIO therapy

Gwen, living with ALS
Image
Amylyx Care Team (ACT)™ Support Program Logo

The Amylyx Care Team (ACT)™ Provides Support You Can Count On

The ACT Support Program is designed to help provide you with support as you start and continue on your RELYVRIO prescription that your doctor has prescribed.

If your doctor has decided that RELYVRIO is right for you, that’s when ACT comes in. ACT is a personalized support program designed to help meet your individual needs as you start and continue on RELYVRIO.

ACT team members are available to assist you Monday through Friday, 8:00 AM to 8:00 PM ET

IMPORTANT SAFETY INFORMATION

Before you receive RELYVRIO, tell your doctor about all of your medical conditions, including if you:

  • Have pancreas, liver, or intestinal problems
  • Have heart failure, including congestive heart failure
  • Have high blood pressure
  • Have kidney problems
  • Are pregnant or plan to become pregnant. It is not known if RELYVRIO will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if RELYVRIO passes into your breast milk. You and your doctor should decide the best way to feed your baby

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements and any taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).

RELYVRIO may affect the way other medicines work, and other medicines may affect how RELYVRIO works.

What are the possible side effects of RELYVRIO?

RELYVRIO may cause serious side effects, including:

  • Changes in bile acid levels. RELYVRIO may increase bile acid levels and cause worsening diarrhea if you already have problems with your liver, bile ducts, or pancreas. Your doctor should monitor you for these side effects. Some disorders of the pancreas, bile ducts, or intestines may also make it harder to absorb RELYVRIO
  • Salt (sodium) retention. RELYVRIO contains a high amount of salt. For people who are sensitive to salt intake, such as people with heart failure, high blood pressure, or kidney problems, limit the amount of salt you eat and drink. Talk to your doctor about the total amount of daily salt that is right for you. Your doctor will monitor you for signs and symptoms of salt retention during your treatment with RELYVRIO

The most common side effects of RELYVRIO include diarrhea, abdominal pain, nausea, and upper respiratory tract infection.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELYVRIO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch(opens new window) or call 1-800-FDA-1088.

WHAT IS RELYVRIO?

RELYVRIO is a prescription medicine used to treat adults with amyotrophic lateral sclerosis (ALS).

For additional information, please see the Summary of Information About RELYVRIO(opens a PDF document in a new window).

IMPORTANT SAFETY INFORMATION

Before you receive RELYVRIO, tell your doctor about all of your medical conditions, including if you:

  • Have pancreas, liver, or intestinal problems
  • Have heart failure, including congestive heart failure
  • Have high blood pressure
  • Have kidney problems
  • Are pregnant or plan to become pregnant. It is not known if RELYVRIO will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if RELYVRIO passes into your breast milk. You and your doctor should decide the best way to feed your baby

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements and any taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).

RELYVRIO may affect the way other medicines work, and other medicines may affect how RELYVRIO works.

What are the possible side effects of RELYVRIO?

RELYVRIO may cause serious side effects, including:

  • Changes in bile acid levels. RELYVRIO may increase bile acid levels and cause worsening diarrhea if you already have problems with your liver, bile ducts, or pancreas. Your doctor should monitor you for these side effects. Some disorders of the pancreas, bile ducts, or intestines may also make it harder to absorb RELYVRIO
  • Salt (sodium) retention. RELYVRIO contains a high amount of salt. For people who are sensitive to salt intake, such as people with heart failure, high blood pressure, or kidney problems, limit the amount of salt you eat and drink. Talk to your doctor about the total amount of daily salt that is right for you. Your doctor will monitor you for signs and symptoms of salt retention during your treatment with RELYVRIO

The most common side effects of RELYVRIO include diarrhea, abdominal pain, nausea, and upper respiratory tract infection.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELYVRIO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch(opens new window) or call 1-800-FDA-1088.

WHAT IS RELYVRIO?

RELYVRIO is a prescription medicine used to treat adults with amyotrophic lateral sclerosis (ALS).

For additional information, please see the Summary of Information About RELYVRIO(opens a PDF document in a new window).