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[ USA ] Amylyx’s ALS drug AMX0035 (U.S. product name Lelyvrio) remove from the market.

This is news update on the failed Phase 3 trial of the ALS drug Relyvrio in the U.S. that we reported on last month. Two weeks ago, on April 4, the voluntary remove of the RELYBVIO drug from the market was officially announced. As a result, Relyvrio can no longer be prescribed to new patients immediately. In an official press release, Amylyx announced that patients currently on therapy in the U.S. and Canada who wish to continue taking RELYVRIO as a treatment, in consultation with their physicians, may be transferred to the Phoenix Open Label Extension, a program that provides the drug free of charge. The AMX0035 trial for Wolfram syndrome and progressive supranuclear palsy ( PSP) will continue. And for ALS, AMX0114, an antisense oligonucleotide that targets calpain 2, will continue to be studied.

Despite being rejected by the FDA once, RELYVRIO successfully convinced an FDA advisory committee to endorse it as a drug candidate for ALS in 2022. The persuasive condition was that they would voluntarily remove the Lelyvrio drug from the market if it did not succeed in a trial called PHOENIX (Phase III clinical trial), according to the Fierce Pharma site.

April 17, 2024 reported by Nobuko Schlough

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