Facing an unfavorable national coverage policy in the U.S., Biogen has called it quits on the observational ICARE AD trial, which was designed to evaluate the safety and effectiveness of its controversial Alzheimer's Disease Aduhelm in clinical practice.
The trial status on clinicaltrials.gov was updated earlier this week to 'terminated.' The update noted that because there will be limited prescriptions written for Aduhelm, the study will not be feasible in terms of enrollment.
The U.S. FDA gave Aduhelm the green light back in June of last year — amid much debate over its effectiveness — making it the first new treatment for the memory-robbing disease in nearly 20 years. Earlier this year, citing unconvincing demonstrations of the drug’s effectiveness, the U.S. Medicare program decided to cover the drug only for patients who were participating in clinical trials.
Although forecasted to become the best-selling drug of all time, Aduhelm tanked when it went on the market, pulling in just $30,000 in sales in the third quarter of 2021 — well below its expected $10.79 million. The hefty yearly cost of Aduhelm, $28,200 per dose, has led to complaints from many consumers who feel it is too high, despite Biogen lowering the price.
The ICARE AD trial, an observational phase 4 study, was one of three programs designed to generate post-approval data on Aduhelm. At the time of its termination, the trial had fallen woefully short of its initial 6000 patient enrollment goal, having enrolled only 29 Alzheimer's Disease patients.
