Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO for the Treatment of ALS - Seite 3

After considering the input of many stakeholders throughout the ALS community in the U.S., Amylyx made the decision to price RELYVRIO below the latest FDA-approved product available to people with ALS. To ensure that every eligible person who can benefit from RELYVRIO will have access, Amylyx will provide support to healthcare professionals, people living with ALS, and their loved ones through the Amylyx Care Team (ACT) Support Program. ACT provides people living with ALS who have been prescribed RELYVRIO, and their loved ones, with a dedicated, single point of contact to guide their treatment journey. ACT works tirelessly to aid with navigating through insurance in an effort to overcome potential barriers to access. ACT helps confirm coverage and provides financial assistance options to eligible individuals with out-of-pocket costs. ACT also provides education, support, and resources to help adults living with ALS get started and continue with RELYVRIO treatment, as prescribed by their healthcare provider. People with ALS, their caregivers, and healthcare professionals in the U.S. can now call 1-866-318-2989 or email [e-mail] to speak with an ACT team member.

Investor Conference Call Information

Amylyx’ management team will host a live conference call and webcast at 8:00 a.m. ET on September 30, 2022 to discuss the FDA approval of RELYVRIO. All interested parties are invited to access a live broadcast of the call via a webcast, which will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at investors.amylyx.com/news-events/events. An archived webcast will be available on the Company's website approximately two hours after the conference call and will be available for 30 days following the call.

About the CENTAUR Trial

CENTAUR was a multicenter Phase 2 clinical trial in 137 participants with ALS encompassing a 6-month randomized placebo-controlled phase and an open-label extension (OLE) long-term follow-up phase. The trial met its primary efficacy endpoint.

Detailed safety and functional efficacy data from CENTAUR were published in the New England Journal of Medicine. Data from additional analyses from the CENTAUR trial were published in Muscle & Nerve in 2020 and 2022, and the Journal of Neurology, Neurosurgery and Psychiatry in 2022.

The CENTAUR trial was funded, in part, by the ALS ACT grant and the ALS Ice Bucket Challenge, and was supported by The ALS Association, ALS Finding a Cure (a program of The Leandro P. Rizzuto Foundation), the Northeast ALS Consortium, and the Sean M. Healey & AMG Center for ALS at Mass General.