It is generally illegal for Americans to import drugs that are not approved in the United States for personal use. But the FDA website lists some exceptions that may apply to albricosa, including if the drug has no serious safety issues and if it is treated as “a serious condition for which no effective treatment is available in the United States.”
Director of the ALS Global Center for Excellence at the Montreal Neurological Institute. Angela Genz, who received a fee from Amelix for working on an advisory board, said American patients would be legally able to receive Albrioza in Canada if it was determined by one. Obtained from Canadian physicians and Canadian pharmacies, although they may not be eligible for insurance coverage under the Canadian public or private system.
In an interview, Mr. Cohen and Mr. Kelly declined to disclose the price they are considering for Amelix Albrioza, saying it is still under discussion. They said the therapy would be available within about six weeks to those who are paying privately, but it would take more, perhaps a few months, to get coverage under the Canadian public system. Amylyx is already providing free albrioza to 250 patients in the United States under sympathetic-use arrangements, they said.
Until last summer, the FDA recommended that the drug would not apply for amilix approval until the end of its Phase 3 trial, but in July, officials began advising that amilix would submit an application for approval using existing data. The timing of the approval of the new Alzheimer’s drug, Aduhelm, followed the vocal pressure of ALS advocacy groups, which was controversial because many experts said there was not enough information to make Aduhelm work.
In the Phase 2 trial, two-thirds of the 137 participants received albrioza, and over a 24-week period, they experienced a 25 percent slower decline than the participants receiving placebo – 2.32 points lower on the 48-point ALS scale than the 12 physical fitness rate. Including walking, talking, swallowing, dressing, handwriting, and breathing.
The open-label extension study included 90 of those patients, including 34 from the placebo group, who started taking the drug approximately seven months after taking it. Those who received the longest treatment had a longer period of 4.8 months before being hospitalized, placed on a ventilator or dying, Amylyx reported. Researchers involved in the study released more data last month that suggested additional benefits.