“Approval in Canada could only increase the pressure the FDA faces to govern and approve this product in its favor,” he added.
It is generally illegal for Americans to import medicines that are not approved in the United States for personal use.But the FDA website List some exceptions This may be the case for Albrioza. This includes cases where the drug has no serious safety issues or treats “a serious condition for which effective treatment is not available in the United States”.
Dr. Angela Genge, director of the ALS Global Center for Excellence at the Montreal Institute for Neurology and receiving a fee from Amylyx for serving on the Advisory Board, said that patients in the United States were prescribed Albrioza in Canada. , Said that it can be legally received. A Canadian doctor and obtained from a Canadian pharmacy, but not covered by insurance under Canada’s public or private system.
In an interview, Cohen and Klee refused to reveal the price Amirix is considering for Albrioza, saying it is still under negotiation. They say that this treatment is available to those who pay personally in about 6 weeks, but it will take longer, and in some cases months, to get compensation under the Canadian public system. I said I would. They said Amylyx already offers Albrioza free of charge to 250 patients in the United States under a compassionate use arrangement.
Until last summer, the FDA recommended that Amylyx not apply for approval until it completes Phase 3 trials, but in July authorities will submit an approval application using Amylyx’s existing data. I started to propose that. Timing was under intense pressure from ALS advocates with the approval of aducanumab, a new drug for Alzheimer’s disease. This was controversial as many experts stated that the data on which aducanumab worked was inadequate.
In the Phase 2 trial, two-thirds of the 137 participants received Albrioza, a 25% slower decrease than those who received placebo over a 24-week period. 48-point ALS scale Evaluate 12 physical abilities such as walking, speaking, swallowing, changing clothes, handwriting, and breathing.
