Relyvrio Regulatory Timeline

21 March 2016

Pre-IND meeting

April 2017

IND accepted

July 2017

AMX0035 granted orphan drug designation

20 April 2018

Fast-track designation denied because the Phase II CENTAUR trial was not adequately designed to show benefit over currently available therapies

17 September 2018

Fast-track designation denied

12 March 2020

Type C meeting on top-line results of CENTAUR; FDA review division questioned ability of the single trial to demonstrate substantial evidence of effectiveness and recommended Amylyx begin work on a second efficacy study

27 March 2020

Breakthrough therapy designation denied because preliminary CENTAUR data did not clearly demonstrate a benefit over currently approved therapies

4 February 2021

Type C meeting; review division reiterated that another randomized, placebo-controlled study would likely be necessary to support an application

11 May 2021

Review division invited Amylyx to request a pre-NDA meeting because claims of a survival benefit warranted a more thorough consideration of the data

15 July 2021

Pre-NDA meeting; review division inquired about the ability to submit an NDA expeditiously to allow for earlier review of the data

October 2021

NDA submitted

November 2021

PHOENIX Study initiated

3 January 2022

Marketing authorization application submitted to European Medicines Agency

30 March 2022

Peripheral and Central Nervous System Drugs Advisory Committee votes 6-4 that data from the CENTAUR trial and the open-label extension do not establish a conclusion that AMX0035 is effective

3 May 2022

Late-cycle meeting

1 June 2022

FDA recommends Amylyx integrate additional survival analyses and biomarker data into a single submission as a major amendment.

3 June 2022

Amylyx announces PDUFA date extension to 29 September

10 June 2022

Health Canada approves Albrioza under its Notice of Compliance with Conditions policy

17 June 2022

Major amendment submitted

29 June 2022

Original PDUFA goal date

1 July 2022

FDA informs Amylyx of plans to reconvene PCNSDAC

7 September 2022

PCNSDAC votes 7-2 that the available evidence of effectiveness is sufficient to support approval

29 September 2022

FDA approval

Amylyx's Relyvrio: The Road To Regulatory Flexibility And US FDA Approval

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