Relyvrio was officially approved by the FDA for treating ALS in September 2022. However, according to an article in BioPharma Dive, there was considerable controversy surrounding the clearance of the drug. Although the FDA initially requested that the developer begin another large trial, it approved the drug before the trial results were disclosed.
The FDA approval was the result of the positive endpoints from a smaller study. In that study, the condition of patients who received treatments declined at a slower rate than those who received a placebo. In addition, these patients lived somewhat longer.
Relyvrio treatments cost $158,000 per year and has surpassed initial revenue expectations. The drug generated over $71 million so far this year.
The Committee for Medicinal Products for Human Use (CHMP) which meets this month, advises the European Medicines Agency. CHMP has indicated that it may not recommend approval of the Relyvrio drug. The CHMP meets this month. Amylyx has full confidence in the results from the key trial of Relyvrio. It indicated that if the drug receives a negative verdict, the company will request a formal re-examination that may last about four months.
It is noteworthy that there have been no new product approvals in the EU for ALS in the past twenty-five years. Access to safe as well as effective treatment options is urgently needed.
