Biogen target Alzheimer's drug approval giving renewed hope to patients

In a surprise announcement, pharma company Biogen has revealed it is set to pursue FDA approval for its Alzheimer’s drug aducanumab, which was previously discontinued in March earlier this year.

Aducanumab was discontinued earlier this year after data from 1,748 patients predicted that the drug was unlikely to be effective. Now, Biogen has decided to once again target regulatory approval for aducanumab after analysing additional data for the drug.

The company says the additional data show that aducanumab is ‘pharmacologically and clinically active’ and can reduce the clinical decline of Alzheimer’s disease. More so, if approved, aducanumab would be the first drug to show the clinical benefits of removing amyloid beta – a type of protein that is thought to be a key contributor to Alzheimer’s disease.

Biogen believes that the additional data show promise due to patients’ taking a higher dose of aducanumab, resulting in ‘significant benefits on measures of cognition and function such as memory, orientation, and language’.

“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” said Michel Vounatsos, chief executive officer at Biogen. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”

Biogen plan to submit a Biologics License Application (BLA) to the FDA in 2020 and will work towards international regulatory approval as well. The company will offer access to  the treatment to patients who previously enrolled in the Phase 3 studies of aducanumab.

In response to the announcement, Dr James Pickett, Alzheimer’s Society head of research said:

"This is hugely exciting news. After the trial being stopped earlier this year because it appeared not to work, further analysis suggests that it does benefit people with dementia in the earliest stages. We’re waiting for further data but this could be the first new treatment for Alzheimer’s disease in over 15 years, and as such, has the potential to be a transformative discovery.

"Alzheimer’s Society has a proud history of funding dementia research, including critical discoveries that have made today’s news possible. We will work alongside the company, regulators and people affected by dementia to understand the difference this could make to families and, if appropriate, to ensure people can benefit from this medical breakthrough in the future."

After the announcement, Biogen's shares rocketed up by 42% adding billions to its market value.