Biogen Announces Pursual of FDA Approval for Aducanumab

Biogen Announces Pursual of FDA Approval for Aducanumab

Biogen and its Japanese partner Eisai announced Oct. 22nd an unexpected reversal—pharmaceutical giant Biogen said it will pursue US Food and Drug Administration approval for aducanumab, an experimental treatment for early Alzheimer’s disease.

Why is This so unexpected?

Phase 3 clinical studies of aducanumab were discontinued in March. The trials were halted because results of a futility analysis found they were unlikely to meet their primary goals at completion.

However, Biogen announced that a new analysis, which included more patients, showed a significant reduction in clinical decline in one trial. Results for some patients in another study support those findings, as well. The data showed that patients who received aducanumab experienced significant benefits on measures of cognition and function, including memory, orientation and language, according to Biogen.

Future Plans

The company Biogen said it will file an application with the FDA in early 2020 and will continue discussions with regulatory authorities in Europe and Japan. It will also offer access to aducanumab to eligible patients previously enrolled in the phase 3 studies.

Anticipation is High

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, and that’s projected to rise to nearly 14 million by 2050.

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