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Lilly, Biogen, Eisai brace for Alzheimer’s boom or bust in 2023

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It is the best of times and the worst of times for the Alzheimer’s space as 2023 is off to an eventful start.

Successful treatments are so tantalizingly close to making a difference for patients, but roadblocks are still aplenty, whether they come from trial design, regulatory ambiguity or even alleged tampering of the approval process. The situation has the field on the edge of greatness with several pharma companies vying for that first unobstructed step forward.

The ramshackle launch of Biogen and Eisai’s Aduhelm in 2021 exposed the pitfalls of navigating the regulatory process with less-than-perfect clinical results. And an eagerness to swiftly bring the first disease-modifying candidate to patients may have caused more skepticism in an area already prone to disagreement.

The FDA’s approval process for Aduhelm was “rife with irregularities,” according to a congressional investigation released just before the new year. The report showed “lapses in protocol” that raised “serious concerns” for both the regulatory process and Biogen’s price-setting after a year-and-a-half-long investigation.

Now, two more drug candidates — donanemab from Eli Lilly and lecanemab from the same partnership between Eisai and Biogen — are on the immediate horizon. One thing is clear: The approval processes for these molecules need to be flawless and transparent to avoid any of the confusion and false hope that befell Aduhelm.

An end in sight

After Aduhelm’s rocky launch and ultimate market demise, Eisai and Biogen are back in the driver’s seat for an imminent decision from the FDA on their follow-up drug lecanemab, which works the same way by clearing amyloid plaques in the brain.

That regulatory decision for potential accelerated approval — the same type that Aduhelm was granted — is expected this week. Eisai is taking the lead this time and has appeared to distance itself from partner Biogen in the matter, according to a November note from Mizuho analyst Salim Syed. In a presentation of results at the time, the Japanese company did not utter “Biogen” once.

“Moving into the slowing of progression for those that aren’t yet experiencing any symptoms is an exciting evolution for the field.”

Dawn Brooks

Global development leader of Alzheimer’s disease, Eli Lilly

But the results spoke for themselves, and lecanemab looks like a strong candidate, Syed said.

“The data overall continued to look great, and any ‘holes’ were in the subgroup analyses, none of which though are likely to tank the thesis that the drug will get approved and used, assuming reimbursement,” Syed said.

The FDA is now in control with a Jan. 6 target PDUFA date, even as the investigation into previous dealings between the companies and the regulatory agency continues.

Failure and persistence

Lilly’s donanemab is the further away from approval of the two newer amyloid-clearing molecules, with confirmatory phase 3 results due by the middle of 2023. Before that, there is also the potential for an accelerated approval by February.

For Lilly, it’s a long time coming. Like its pharma giant peers, the company has suffered setbacks over the years, including the 2016 failure of its drug solanezumab. But unlike companies who left the arena — including Merck & Co. and Pfizer — Lilly stayed the course in Alzheimer’s with donanemab to show for it.

Donanemab’s most recent success came from a head-to-head trial against Aduhelm — an unusual target for a comparison trial given how fresh its approval was —  in which Lilly’s drug cleared amyloid plaque at a quicker rate than Biogen’s beleaguered treatment after six months. The safety of the drugs has been shown to be similar, particularly in the characteristic brain swelling called ARIA.

John Sims, senior medical director of neurodegeneration, Eli Lilly

John Sims, senior medical director of neurodegeneration, Eli Lilly

Permission granted by Lilly


John Sims, senior medical director of neurodegeneration at Lilly, has been working on donanemab for 13 years. Although he’s had a hand in other molecules as well, the Alzheimer’s drug was his first at the company.

“We’ve had lots of failures along the way, but what’s been key here is that we kept at it,” Sims said in an interview. “We have to learn from each one of these and do each next stage a little bit better — many of us, including me, have had family members really suffering from this disease and who died from this disease, and it’s been an unsolved pain in society that has needed some kind of persistence.”

The company’s Alzheimer’s journey stretches back even further than Sims’ tenure, said Dawn Brooks, global development leader of Alzheimer’s disease at Lilly.

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