Improving Amylyx’s ALS Drug Relyvrio: Taste Masking and Withdrawal
1. Amylyx Pharmaceuticals' ALS drug, Relyvrio (a combination of two older drugs), has a bitter taste, which can be unpleasant for patients.
2. Amylyx is developing a 'taste-masked' version of Relyvrio to improve the patient experience.
3. Relyvrio was approved by the FDA in September 2022, following a years-long advocacy campaign by ALS patients.
4. However, a large clinical trial in March 2024 revealed that Relyvrio did not show any improvements in survival or other health measures, leading to its voluntary withdrawal from the U.S. and Canadian markets.
5. Amylyx's co-CEOs, Joshua Cohen and Justin Klee, publicly promised to withdraw the drug if further testing failed to show a benefit, and they made good on that promise.
6. The withdrawal of Relyvrio leaves only three ALS medicines available to U.S. patients, with only one of them shown to extend survival by several months.
7. The patent life of the drug is not directly related to its taste or efficacy, but to the duration of the intellectual property protection granted by the patent system.
In summary, Amylyx is working on a taste-masked version of Relyvrio to improve patient experience, but the drug has been withdrawn from the market due to its ineffectiveness in a large clinical trial. The patent life of the drug is a separate issue and would not be directly affected by taste or efficacy.