Amylyx, the maker of a drug to treat ALS, is pulling the drug from the market and laying off 70 percent of its workforce after disappointing trial results. The drug, called Relyvrio, won FDA approval but failed to meet its goals in a large clinical trial. The company is now focusing on other drug candidates and will provide Relyvrio to existing patients through a free drug program.
Key Takeaways
- Amylyx, the maker of the ALS drug Relyvrio, is pulling it from the market and laying off 70% of its workforce after it failed to show benefits in a large clinical trial.
- The drug was approved by the FDA in 2022 despite shaky data and FDA advisers initially voting against approval.
- Relyvrio failed to meet any of the trial's goals, showing no improvements in patients' physical functions, quality of life, respiratory function, or overall survival.
- Relyvrio, with a list price of $158,000, will no longer be available to new patients, effective immediately. Existing patients can continue through a free drug program.
- Amylyx is now focusing on two other drug candidates for different neurodegenerative diseases and will lay off more than 350 employees as part of the restructuring.
News Content
The maker of a drug to treat ALS is pulling the drug from the market and letting go of 70% of its employees. The drug, Relyvrio, was approved by the FDA in 2022, but a recent large clinical trial found it did not help patients. Despite shaky data and initial FDA adviser disapproval, the drug was granted approval due to the severity of ALS and lack of effective treatments. With a list price of $158,000, the drug failed to meet any of the trial's goals and will no longer be available to new patients, with the company considering a voluntary withdrawal from the market. Additionally, the company will focus on two other drug candidates to treat different neurodegenerative diseases.
The news reflects a trend of controversial drugs gaining FDA approval despite questionable data for devastating neurodegenerative diseases. The withdrawal of Relyvrio comes after the similar abandonment of a highly contentious Alzheimer's drug earlier in the year. This indication suggests a growing scrutiny of drug approvals and emphasizes the challenges associated with developing effective treatments for complex diseases.
The company has also indicated a commitment to continue providing the drug to existing patients through a free drug program. Despite the setbacks, the company is now restructuring its focus on two other potential drugs for different neurodegenerative diseases, and this significant change includes laying off more than 350 employees.
Analysis
The withdrawal of the drug Relyvrio and layoff of 70% of employees underscores the FDA's approval of controversial drugs based on questionable data for severe neurodegenerative diseases. Short-term consequences include the drug's unavailability and job losses, while the long-term impact highlights the challenges of developing effective treatments. The company's commitment to providing the drug to existing patients and focusing on two new drug candidates signals its resilience. This development emphasizes the growing scrutiny of drug approvals and the complexities associated with addressing devastating diseases, indicating a trend that demands heightened regulatory scrutiny and careful clinical evaluation for such medications in the future.
Do You Know?
- FDA Approval Process: The approval of the drug Relyvrio by the FDA in 2022 despite shaky data and initial disapproval from FDA advisers highlights the complex and controversial process of gaining approval for treatments of devastating neurodegenerative diseases.
- Voluntary Withdrawal from Market: The decision of the company to withdraw Relyvrio from the market due to the drug's failure to meet trial goals and lack of effectiveness reflects the challenges associated with developing effective treatments for complex diseases, and emphasizes a growing scrutiny of drug approvals.
- Company Restructuring and Commitment to Existing Patients: The company's restructuring focus on developing two other potential drugs for different neurodegenerative diseases, while also committing to provide Relyvrio to existing patients through a free drug program, demonstrates a dedication to continuing patient care despite setbacks.