Massachusetts-based biotech company Biogen has presented the US Food and Drug Administration (FDA) with "exceptionally persuasive" evidence that its experimental Alzheimer's disease drug was effective, marking a major step towards winning approval.
Biogen
If aducanumab goes on to ultimately be approved, it would be the first new drug to combat Alzheimer's in the US for decades.
When the news broke, Biogen shares skyrocketed by 44% to a two-year high, instantly adding almost $17 billion (€14.37 billion) to the company's market value and bringing it to just under $55 billion (€46.5 billion).
The prospects for aducanumab have been the subject of intense focus by patient groups and investors throughout its development, with hopes being raised and then dashed on several occasions.
Yesterday, the FDA published a lengthy and positive clinical review on aducanumab, addressing concerns that there was insufficient evidence of the drug's efficacy following the failure of one of two clinical trials by Biogen. They said that the failed trial did not "meaningfully detract" from the results of the successful trial, which it described as "robust and exceptionally persuasive".
Biogen has claimed that the clinical data show aducanumab slows down Alzheimer’s patients’ memory loss, language and executive functions. The drug targets clumps of protein called beta amyloid that can build up in the brain.
“The applicant has provided substantial evidence of effectiveness to support approval,” the FDA reviewers wrote in their report.
While the document is not a final decision it does give an indication of how the Agency will look at Biogen's submission.
Nearly 50 million people worldwide - more than the population of Colombia - are affected by Alzheimer's disease. Biogen estimates that around 1.5 million early Alzheimer's sufferers in the US could be candidates for aducanumab.
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