The manufacturer of a controversial ALS medicine , Relyvrio, said that it is discontinuing the drug’s distribution after unsatisfactory study findings.
Relyvrio did not improve patient outcomes in a significant follow-up trial, according to a statement released by Amylyx Pharmaceuticals on Thursday. As a result, the medication “will no longer be available for new patients as of today.” The drug is available in Canada under the name Albrioza.
The co-CEOs of Amylyx, Joshua Cohen and Justin Klee, stated in the statement that “the decision to remove RELYVRIO/ALBRIOZA from the market and provide therapy free of charge for those who wish to continue was informed by the PHOENIX trial results, engagement with regulatory authorities, and discussions with the ALS community.” “Thank you to each and every person who shared feedback with us and continues to support our commitment to the ALS community.”
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Manufacturer Relyvrio
The business stated that as of Thursday, “patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to continue can be transitioned to a free drug program.”
Relyvrio is a combination of two earlier medications: a dietary supplement linked to traditional Chinese medicine and a prescription treatment for liver diseases.
Relyvrio, which lists for $154,000 a year, is presently being used by roughly 4,000 ALS patients, according to the New York Times.
The U.S. Food and Drug Administration first approved Relyvrio in September 2022 as a result of a protracted, passionate campaign spearheaded by people suffering from the deadly muscle-wasting disease ALS.
Regretfully, the most recent research, known as PHOENIX, revealed the medication had no effect on slowing the progression of the illness when compared to a placebo, nor did it improve any secondary outcomes, such as muscular strength.
The debilitating neurological condition known as ALS gradually deteriorates the nerve cells and connections required for breathing, walking, talking, and speaking. The majority of patients pass away three to five years after being diagnosed.
The FDA’s scientists questioned the findings of a single tiny trial, which served as the primary foundation for Relyvrio’s clearance. A panel of independent experts first opposed the medication, but after patients asked for a follow-up meeting, the committee was persuaded to support it. Amylyx announced at the time that it was carrying out a bigger follow-up trial including over 600 patients, which would yield further information about the medication.
During that second advisory committee meeting, Amylyx officials made an extremely unexpected announcement to FDA regulators: they would remove the medication from the market if additional studies failed to validate its effectiveness. FDA advisors appeared to be comforted by the pledge, and they went on to vote in support of the drug’s approval in spite of the dubious facts.
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