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Canada OKs ALS Therapy

Regulators in Canada have approved a new therapy from Amylyx Pharmaceuticals to treat amyotrophic lateral sclerosis, the New York Times reports.

It notes that the treatment, AMX0035 or Albrioza, is a combination of taurursodiol and sodium phenylbutyrate that was thought up by the founders of Amylyx, Justin Klee and Joshua Cohen, when they were undergraduates at Brown University. They speculated, the Times notes, that the two together could protect mitochondria and endoplasmic reticula within neurons affected by the disease.

According to the Times, Canadian officials have OK'd the therapy under a type of accelerated approval program though which treatments for serious conditions are allowed even if the supporting evidence is incomplete. It adds that as a condition of the approval, the company has to "verify the clinical benefit" of the treatment through an ongoing phase 3 clinical trial.

Earlier this year, a US Food and Drug Administration panel that reviewed a phase 2 study and an open-label extension study of the treatment was not convinced that it was effective. While the US also has an accelerated approval program, the Times says the therapy is unlikely to be approved under it as its version requires the treatment to target the underlying disease mechanism and too little is known about the biology of ALS.

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