New Alzheimer’s Drug Slows Cognitive Decline by 27%

A new Alzheimer’s drug from Japanese pharmaceutical company Eisai and US drugmaker Biogen has shown promising results in a large-scale clinical trial. The companies announced the trial’s success in a press release, saying their drug — called lecanemab — was observed to have slowed cognitive decline in Alzheimer’s patients by 27% over 18 months.

The companies said 1,795 patients with early-stage Alzheimer’s were randomly selected to receive a placebo treatment or doses of lecanemab every two weeks. Their cognitive decline was then measured on six fronts, including “memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.” According to the statement, lecanemab significantlyreduced clinical decline” over the 18-month timeframe.

Lecanemab, per Eisai, is a monoclonal antibody treatment, which targets toxic amyloid plaques protein clumps that researchers proposed were the cause of the neurodegeneration seen in Alzheimer’s.

The companies noted that around 21% of the patients who received the lecanemab treatment experienced brain swelling that was visible on PET scans.

Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Michel Vounatsos, Biogen‘s chief executive officer in the companies’ joint press release.

Eisai’s chief executive Haruo Naito said in the company’s press release that the lecanemab study’s success was “an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer’s disease community.”

Source: https://investors.biogen.com/
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Biogen Nabs Speedy FDA Review For Alzheimer’s Drug

Biogen’s aducanumab is inching closer to an FDA decision. The Big Biotech, along with partner Eisai, announced  that the FDA accepted its regulatory submission for aducanumab, its once-failed Alzheimer’s drug—with priority review to boot. The agency expects to decide the fate of the treatment by March 7. Along the way, it will hold an advisory committee meeting. It has not set a date for the meeting, but Jefferies analyst Michael Yee expects it sometime in the first quarter of 2021.

The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive Officer at Biogen.

How the FDA rules on aducanumab will show how far the FDA and its commissioner, Stephen Hahn, M.D., are willing to diverge from its established approval standards. Under U.S. law, companies need to show “substantial evidence of effectiveness to win approval.

Source: https://investors.biogen.com/

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