Biogen and Eisai announce plans to file for market approval of Alzheimer’s drug

Biogen and Eisai have announced they will file for market approval for an investigational treatment for early Alzheimer’s disease.

Biogen and Eisai today announced that they will file for market approval for the drug aducanumab, an investigational treatment for early Alzheimer’s disease, following new analysis showing reduced clinical decline in people with early Alzheimer’s disease.

The Phase 3 clinical studies ENGAGE and EMERGE were discontinued in March 2019 following futility analysis by an independent monitoring committee that indicated the trials were unlikely to succeed.

Following the discontinuation of EMERGE and ENGAGE, additional data from these studies became available. After reviewing this larger dataset from the Phase 3 EMERGE Study in close consultation with the U.S. Food and Drug Administration (FDA), Biogen found that aducanumab resulted in significant benefits to patients. These improvements related to cognition and function including memory, orientation, and language, as well as improving daily activities like conducting personal finances, performing household chores, and independently traveling out of the home.

The discrepancy between the earlier futility analysis of the drug and the new analysis of the larger dataset is largely due to patients’ greater exposure to high dose aducanumab.

Alzheimer’s disease is the most common form of dementia, the collective term for a range of degenerative neurological conditions that affect memory, thinking, behaviour and emotion. There is no cure for dementia and has been no new treatment for the symptoms of dementia since 2002.

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.

Paola Barbarino, Chief Executive Officer of ADI, said:

This amazing therapeutic breakthrough from Biogen is like a ray of sunshine, the first we have had for a long, long time. I cannot overemphasise the importance of this announcement today as it will give also renewed impetus to markets for the discovery of more pharmaceutical treatments. I want to stress to all those living with dementia now that aducanumab is not yet approved and further submissions will be made to regulators but it is the light at the end of the tunnel we have been hoping for so long!

Samantha Budd Haeberlein, Vice President, Late-Stage Clinical Development at Biogen, said: “We believe that these positive results for aducanumab represent a turning point for patients, caregivers, physicians, and scientists in the fight against Alzheimer’s disease. We look forward to working with the FDA and regulators around the world to find a path to make the drug available to patients. Most importantly, we envisage a future where physicians may finally have an option to offer patients to help reduce clinical decline in Alzheimer’s disease.”

Kate Swaffer, Chair, CEO and Co-Founder of Dementia Alliance International (DAI), said: “It is with both excitement, but also some apprehension that people diagnosed with dementia receive this news. For too long the focus was only on a cure, and we have also had many failed trials. To know we may be close to a disease modifying drug, as we have for so many other chronic conditions such as diabetes, increases hope for us all.”

We are assured that Biogen will work to gain market approval for aducanumab as soon as possible, working closely with regulatory authorities, institutional review boards and principal investigators. They plan to submit their Biologics License Application to the FDA by early 2020 and will continue dialogue with regulatory authorities in international markets.

The clinical trial for this drug is not open to new patients at present, but Biogen aims to offer aducanumab to eligible patients previously enrolled in clinical studies. ADI will continue to work closely with Biogen and Eisai, and to advocate for improvements in detection and diagnosis, availability of specialists and access to healthcare centres, to support the eventual roll-out of aducanumab.

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