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An update from Amylyx adapted from two Biopharma Dive articles:
Approximately 3,800 PALS 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.
Sales during the first quarter widely beat forecasts and, in the second quarter, did so again: $98 million in the U.S. and Canada.
Amylyx 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 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.”
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 EMEA's recommendation, a process that he expects to take about four months.
More than 30,000 ALS patients live in Europe by Amylyx’s estimates. One analyst estimates an 80% probability that the drug will ultimately get a green light in Europe.
Approximately 3,800 PALS 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.
Sales during the first quarter widely beat forecasts and, in the second quarter, did so again: $98 million in the U.S. and Canada.
Amylyx 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 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.”
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 EMEA's recommendation, a process that he expects to take about four months.
More than 30,000 ALS patients live in Europe by Amylyx’s estimates. One analyst estimates an 80% probability that the drug will ultimately get a green light in Europe.
