Amylyx ALS drug sales tick higher after fast US launch

11 Aug 2023
www.biopharmadive.com
Drug Approval
Use of Amylyx Pharmaceuticals’ recently approved ALS drug Relyvrio continues to grow in the U.S., where it was launched last fall.
Approximately 3,800 people with ALS, or amyotrophic lateral sclerosis, were taking Relyvrio at the end of June, Amylyx said in a conference call held Thursday to discuss the company’s second quarter earnings. That’s a step up from the estimated 3,000 patients who were on treatment as of March 31.
The drug’s launch has gone better than the company and analysts on Wall Street had expected. Sales during the first quarter widely beat forecasts and, in the second quarter, did so again, with Amylyx reporting $98 million in sales of Relyvrio in the U.S. and Canada. Analysts were predicting around $91 million.
AmylyxAmylyx, which set the drug’s list price at $158,000 for one year’s supply, aims to have about 10,000 people taking Relyvrio in the U.S. at any given time. While uptake has been strong, Margaret Olinger, the company’s commercial head, noted that roughly half of all Relyvrio prescriptions were written by just over 80 physicians, mostly at major ALS treatment centers.
On Thursday’s call, analysts pressed Amylyx executives on trends in Relyvrio prescriptions, particularly whether patients were discontinuing treatment. Olinger pointed to the drug’s main supporting clinical trial, during which about 70% of participants remained on treatment through the six-month study. Commercial use has been “tracking close to that,” Olinger said.
Relyvrio was approved by the Food and Drug Administration last September. Data from testing showed treatment modestly slowed patients’ decline on a rating scale used to assess ALS symptoms. Further analysis also associated the drug with a survival benefit of about five months compared to placebo.
Still, FDA staff had raised a number of concerns with Amylyx’s data and an advisory committee initially voted against the drug, before supporting it in a second meeting.
Only two other medications, known as Radicava and riluzole, are commercially available for ALS treatment in the U.S. Both are meant to slow functional decline, but neither are associated with dramatic benefit.
Amylyx also sells the drug in Canada, where it’s branded as Albrioza. It’s trying to win approval in Europe, but regulators there issued a negative opinion in June, blocking the drug’s path to market for now.
Justin Klee, Amylyx’s co-CEO, said Thursday that the company is appealing the European Medicines Agency’s recommendation, a process that he expects to take about four months.
“You can expect that near the end of this year we’ll hear back regarding that opinion,” Klee said.
Amylyx shares traded flat Friday morning.
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