How Do Companies Avert Further Frustration among Neurologists Due to Relyvrio’s (Amylyx) Phase 3 Failure and Donanemab’s (Lilly) FDA delay?
ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.
- ALS strikes adults in the prime of their life, is fatal, and the life expectancy of patients is generally 15 years or less.
- ALS patients maintain their cognitive functions while their muscle function deteriorates and eventually renders them bed-ridden, unable to swallow, and unable to breathe.
- In an unusual decision the FDA conditionally approved Relyvrio based on the Phase 2 results as long as Phase 3 trial outcomes confirmed the results.
- Only 40% of neurologists were initially aware of the FDA announcement regarding donanemab for Alzheimer's Disease (AD) when prompted.