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Biogen/Eisai push for second approval in Alzheimer’s disease

As well as announcing strong expectations for their newly approved drug, Biogen and Eisai are already in communications with the FDA about a pathway to approval for its follow-up, lecanemab

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Brushing aside the controversy surrounding the FDA approval of its breakthrough Alzheimer’s drug, Aduhelm (aducanumab), Biogen and Eisai have made confident predictions about future treatment of the disease.

As well as announcing strong expectations for their newly approved drug, Biogen and Eisai are already in communications with the FDA about a pathway to approval for its follow-up, lecanemab (BAN2401).

The comments come after the announcement by Eli Lilly CEO Dave Ricks about the company’s intention to seek a filing for donanemab. Both drugs received Breakthrough Therapy Designation earlier this year.

Analysts predict antibody treatments – including Biogen/Eisai’s aducanumab and lecanemab, Lilly’s donanemab and Roche’s gantenerumab – could become megablockbusters, bringing in billions in annual sales.

With the WHO expecting 152 million people to suffer with dementia by 2050 (60-70% of which will be Alzheimer’s), and with no other treatments available, the new drugs could be a win-win for both patients and pharma.

In a presentation to analysts, Eisai neurology chief Ivan Cheung said: “Under the breakthrough therapy designation from the FDA we have initiated communications with the FDA to seek the most optimal and expedited regulatory pathway forward for lecanemab. We will explore all options with the FDA, we will listen to their advice, including the accelerated approval pathway.”

Michael Yee, managing director of investment bank Jefferies, said: “BAN-2401 has a very strong plaque reduction effect similar to LLY (Eli Lilly), although ROG (Roche) may have a lesser effect. BAN2401 may also have less ARIA (amyloid-related imaging abnormalities) side effects than Aduhelm and does not require titration.”

However, all may not be plain sailing for the drugmakers. The FDA’s decision to approve Aduhelm in June was criticised by many for resting on incomplete phase 3 results. In July, the FDA’s acting commissioner Janet Woodcock asked the Office of the Inspector General to conduct an independent review of all interactions between the FDA and Biogen around the approval of Aduhelm. ICER has also criticised the $56,000 US price.

Two months on, many doctors remain reluctant to prescribe the drug. “I do think providers are hesitant,” said Eric Reiman, CEO of the Banner Alzheimer's Institute. “We have a drug that, in my opinion, is more likely than not to have a clinical benefit. But that's uncertain.”

Many hospitals and treatment centres in the US have yet to decide on how and when to use Aduhelm, with Biogen stating that two-thirds of the 900 centres initially targeted have yet to agree a policy.

Article by
Hugh Gosling

5th August 2021

From: Research, Regulatory

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