DUBAI, United Arab Emirates (CNN) – In an unexpected move, the drug giant Biogen announced that it would seek FDA approval for Aducanumab as an experimental treatment for early Alzheimer's disease.
The third phase of clinical trials with adukanumab was discontinued in March because the results of the analysis showed that achieving its primary goals after completion is unlikely.
Biogen announced that the new analysis, which included more patients, showed a significant clinical decline in one study. Similarly, the results of some patients in another study confirmed these findings.
According to the company, the data showed that patients who took the drug received significant benefits in terms of cognition and function, including memory and language.
“ I really hope that this new analysis will end & # 39; & # 39; – said Dr. Richard Isaacson, director of Alzheimer & # 39; s Prevention Clinic at Weill Cornell Medical in New York, who had patients in the original clinical studies, adding that he was not surprised that re-analysis of the data showed something positive. "I think there will be permanent regulatory obstacles and the drug can be very expensive," he said.
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The company said it will apply to the FDA in early 2020 and will continue talks with regulators in Europe and Japan. Access to the drug will also be provided by eligible patients previously enrolled in the Phase III studies.
"This is the result of groundbreaking research and demonstrates the company's determination to teach and do the right things for patients," said Michel Phonatos, Biogen CEO.
"We hope patients are offered the first treatment to reduce the clinical worsening of Alzheimer's disease and the potential impact of these results on similar beta-amyloid-oriented approaches," he said.
The amyloid hypothesis is that the accumulation of beta amyloid is a major cause of memory destruction. This hypothesis has been the driving force behind Alzheimer's disease research for over 20 years.
However, most attempts to develop amyloid-targeted drugs have failed in people with this disease.
Alzheimer's disease is the sixth leading cause of death in the United States. About 5.8 million people in the United States currently live with Alzheimer's disease, and this number will increase to about 14 million by 2050.
The Alzheimer Society praised Biogen's request for consent from the supervisory authority.