Dear FDA: Please Grant Priority Review to AMX0035 and Approve It

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On Thursday, we asked the FDA to treat the approval review process of AMX0035 with urgency. Specifically, we sent a letter to FDA asking the agency to conduct a Priority Review of Amylyx’s New Drug Application (NDA) for AMX0035 and then approve it. The Priority Review is an expedited review process, as opposed to the Standard Review process, which can take upwards of a year after the agency accepts submission of the NDA.

You can read our letter here.

Our advocacy for swift approval for AMX0035 is just part of our efforts to bring greater speed and effectiveness to the agency. We continue to advocate for a series of policy actions to help the FDA accelerate development and delivery of effective therapies. Here is what else we are doing:

  • In our appropriations request to Congress, we are asking for $50 million for the FDA to fund clinical research to benefit people with ALS. We also are supporting the Promising Pathways Act to give the FDA additional tools to enable earlier access to potential therapies. 
  • We continue to advocate for ACT for ALS legislation which supports access to experimental treatments and provides the FDA additional research capacity and public private partnerships to speed development and approval of new treatments. 
  • We are asking Congress to fund a study by the National Academies of Science and Medicine to help coordinate the entire ALS research agenda.

These efforts all support the FDA so it can do its part in bringing forward better treatments that extend and improve the lives of people with ALS. Now, we need the FDA to act quickly so that people living with ALS and their loved ones can benefit from new life-changing therapies.

Comments

Submitted by: Candace P. on Fri, 11/19/2021

This needs to be approved ASAP. My mother doesnt have much time and anything could help.

Submitted by: Dawn L. on Fri, 11/19/2021

Please approve this

Submitted by: Carolyn P. on Fri, 11/19/2021

This is so important to us AlS is progressing so quickly I would take any trail drug to help myself and others.

Submitted by: Linda F. on Fri, 11/19/2021

I lost my husband of 51 years to this horrible disease. Please act quickly to help those that are suffering.

Submitted by: Susan S. on Sat, 11/20/2021

My brother retired Navy Veternarian of 335 years. Retired just diagnostic with ALS. A good father, husband and brother. One of the great persons in this world.
Please help him.

His sister
Susan Siegel

Submitted by: David S. on Sat, 11/20/2021

Please approve this

Submitted by: Jackie C. on Tue, 11/23/2021

Thank you ALS Association for staying on top of this issue. My husband was diagnosed in Jan 2019. He's been on Radicava since April 2019 however the effect is waning. His disease has progressed rapidly over the last year. FDA proved they could act faster and cut through the red tape in 2020 and 2021 with Covid. I urge FDA to move with the speed of light so this new drug can be available sooner rather than later. Later is too late for many of us!

Submitted by: Tamara L. on Thu, 12/02/2021

My husband was diagnosed a year ago and we are extremely frustrated that access is not made easier and faster to those suffering from ALS; it just seems that any drug that shows promise should be fast-tracked, because there is much to lose by waiting.

Submitted by: Francis H. on Thu, 12/02/2021

I am willing to assume any, and all, risks involved by trying AMX0035. I've gone from world class athlete, to wheelchair bound, with new symptoms appearing regularly. Please FDA...show some compassion!

Submitted by: Steve N. on Thu, 12/02/2021

I am 59 yrs old. Diagnosed with ALS in August 2021. I want to very much to try this treatment. Please, do what you can to help all of us! This is a terrible disease. I hate seeing my family suffer over me!

Submitted by: Diana B. on Thu, 12/02/2021

Please approve!

Submitted by: Anthony S. on Fri, 12/03/2021

Please approve this asap!!
I would like to try this before it is too late for me.

Submitted by: Sue F. on Thu, 12/02/2021

Please get this approved asap! My partner was diagnosed 2 months ago after she just became cancer free. We need help!!!!!

Submitted by: Susan H. on Thu, 12/02/2021

Please!! Time is of essence for everyone suffering with this horrible disease.😂

Submitted by: Claudia C. on Thu, 12/02/2021

Please approve without more delay AMX0035. PALS do not have time to waste in interminable clinical trials. Thousands are diagnosed with ALS every year. Thousands of lives depend on this.

Submitted by: Ron M. on Thu, 12/02/2021

I’ve been living with ALS family over 8 years. Time is quickly running out. Please approve anything that can help all of us affected.

Submitted by: Sharon R. on Thu, 12/02/2021

Please approve as soon as possible. My precious husband of 46 years was diagnosed with ALS in Sept 2021. Please Please Please get this approve! We need help!

Submitted by: Bobbie T. on Thu, 12/02/2021

I was diagnosed with ALS in late 2018. Please help!

Submitted by: Aja J. on Thu, 12/02/2021

Thank You ALS!!!! We need more people and organizations across America to fight for this drug and support for ALS patients. There is little to no treatment. And or facilities that provide care specifically for ALS patients. I’m located in Boston, MA and ALS is becoming more widely known but still there’s no real support other than you! So keep up the great work!!!

Submitted by: S J. on Fri, 12/03/2021

If this will help those suffering with ALS, then by all means please move it forward!

Submitted by: ROBERT P. on Fri, 12/03/2021

Treat us living with ALS as your wife, husband or CHILD! Do you personally know anyone living with ALS?? Have you ever spoken face to face with someone living with ALS?? DO THE RIGHT THING AND RUSH THIS THROUGH!!!’

Submitted by: wynette W. on Fri, 12/03/2021

Time is running out I was diagnosed in 2018, please get everyone treatment for this horrible disease!

Submitted by: Linda L. on Fri, 12/03/2021

We cannot wait, ALS takes so much away from us and our families this needs to be approved ASAP please!

Submitted by: James S. on Sat, 12/04/2021

Nearing 4 years,12-21-2017, legs are almost gone my arms are going. I feel like a T-Rex when I try to use them. No feeling in my feet. Feel so useless and helpless. Let us try a potential drug now.

Submitted by: Glen R. on Sun, 12/05/2021

What about in Nurown you should push for its approval as well.

Submitted by: Amy L. on Tue, 12/07/2021

Hi Glen. We remain committed to advocating for approval of all treatments that are proven safe and effective based on peer-reviewed data. In phase 2, NurOwn met its primary endpoint for safety but was not powered to assess efficacy. Its phase 3 trial was designed to prove efficacy, but it did not meet its primary and secondary endpoints.

Submitted by: Lee P. on Mon, 12/06/2021

Please approve AMX0035 to be used by everyone who has ALS and wants a fighting chance treatment and if it helps reduce the terrible phlegm to help improve my sister in laws respiration

Submitted by: Kathi B. on Wed, 12/08/2021

YES!! TOTALLY NEED to advance quickly on a promising treatment!!
It can be done — such as with AIDS & COVID —
Doesn’t SOMEONE in the FDA OR Government system overall know of ALS and it’s devastation of individual human people with this DREADFUL SPEED disease process! The effect on friends and family is equally devastating — everyone lives & breathes anxiety & frustration over a total lack of treatments ‘in time’ to make a difference in quality or quantity of time to live!

Submitted by: Ellen A. on Wed, 12/15/2021

Please approve AMX0035. People are suffering and dying as the FDA ponders whether this is safe or not. Please let us decide whether we are willing to do all that we can to help ourselves. Time is not on our side.

Submitted by: Jean L. on Fri, 12/17/2021

I was diagnosed April 22,2021 and rapidly loosing strength in my arms & legs. I would definitely take this drug. Hopefully it can help us with this dreaded disease & any diagnosed later.

Submitted by: Jorjann H. on Mon, 12/27/2021

We need this approved asap. Everyday is another lose. Please rush this through.

Submitted by: Jorjann H. on Mon, 12/27/2021

We need this approved asap. Everyday is another lose. Please rush this through.

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