With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch

After Aduhelm’s false start in Alzheimer’s disease, Eisai and Biogen have picked up another accelerated nod in the tough-to-treat neurodegenerative disease.

Friday, the U.S. FDA signed off on the accelerated approval of the partners’ antibody lecanemab, which will now carry the commercial moniker Leqembi.

But after the Centers for Medicare & Medicaid Services’ (CMS') 2022 coverage restriction for anti-amyloid antibodies like Aduhelm and Leqembi, Medicare patients essentially lack access to Eisai and Biogen’s new drug for the time being, Eisai’s U.S. CEO Ivan Cheung said in a recent interview.

Eisai’s plan, then, is to file for a full traditional approval of lecanemab “within days” of the initial OK, Cheung explained late last year. On Monday, the company did just that.

Alongside Eisai’s regulatory efforts, the company has been working with CMS to have the agency review results from lecanemab’s Clarity AD study at the same time as the FDA. The company's goal is for the agency to reconsider its 2022 national coverage decision (NCD), which restricts Medicare coverage of anti-amyloid antibodies to patients in clinical trials.

Given the presence of the NCD, which CMS has said it won’t reconsider until lecanemab sports a full approval, Cheung notes that Eisai plans to take a “phased approach” with its Leqembi launch. The U.S. CEO further broke down the opportunity into three stages.

The first phase will be marked by Leqembi’s initial accelerated approval. During this stretch, the focus will be less on generating sales or demand because Medicare beneficiaries essentially have “no access to lecanemab,” Cheung explained.

Instead, Eisai will focus on working with health systems around the U.S. to “get the patient journey ready,” Cheung said. That will mean ironing out procedures such as screening, diagnosis, infusions and monitoring. Essentially, in anticipation of a full approval, Eisai wants to get the “ecosystem and environment as ready as possible,” Cheung added.

The next phase of lecanemab’s launch counts on CMS lifting its coverage restriction after a full FDA approval. This phase would effectively mark the “real launch of lecanemab across the country,” Cheung said.

Following that phase comes “scale-up or expansion … upon some catalyst events,” Eisai’s U.S. CEO noted, singling out a potential approval for a subcutaneous autoinjector formulation.

For the launch overall, “we’re going to be doing it in a very meticulous, careful way,” Cheung stressed.

The drug's price seems to reflect that approach. The new medicine sports a $26,500 list price, which is less than half the cost of Aduhelm. The Leqembi price came "in-line" with expectations, Mizuho analyst Salim Syed wrote to clients.

Safety questions

Another important factor in the med’s rollout will be to highlight the efficacy seen in Clarity AD while tempering those results with safety data to “ensure appropriate understanding and education of the potential risks of lecanemab,” Michael Irizarry, M.D., deputy chief clinical officer of Alzheimer’s disease and brain health at Eisai, added during the company’s interview with Fierce.

Over the course of the drug's development, three patient deaths potentially tied to lecanemab have dimmed the med’s initial glow, though Eisai has remained emphatic that the situation provided information about the risks patients may need to accept—and the tough conversations doctors will need to have—before starting treatment.

Despite safety caveats, Eisai and Biogen have faith their latest attempt in Alzheimer’s will pay off for certain patients and caregivers.

Lecanemab’s approval hinges on the 1,795-subject Clarity AD study. After 18 months in the phase 3 trial, Biogen and Eisai found lecanemab slowed cognitive decline by 27% versus placebo, allowing the trial to meet its primary endpoint.

Across other outcomes, that figure was “as high as 37% for slowing of progression of functional decline,” Eisai’s Irizarry pointed out. Those results were consistent across patient subgroups and “generalizable to people with a range of comorbidities,” the executive explained.

Charting a paradigm shift in any disease requires a “trigger” or “spark,” Eisai’s Cheung opined. Eisai lit that spark 25 years ago with its earlier Alzheimer’s therapy Aricept, marking “really the first time that people understood that a pharmacotherapy could be helpful for these individuals,” he explained.

Now, the focus in Alzheimer’s is to determine whether pharmaceuticals can address the underlying pathophysiology of the disease, with a view to potentially modifying Alzheimer’s.

Meanwhile, pricing proved a point of contention early in Aduhelm’s launch. Speaking with Fierce before the lecanemab approval decision came down, Eisai’s U.S. CEO Cheung noted it was too early to comment on specific pricing plans, though he noted the company would share more details shortly after the drug’s accelerated OK.

Industry watchers will no doubt be tracking lecanemab’s launch closely after the tumultuous launch of Biogen and Eisai’s first partnered Alzheimer’s med Aduhelm.

While the partners have largely called it quits on that drug, Aduhelm fallout continues to plague Biogen, which was recently put on blast in a congressional report detailing “inappropriate” and “atypical” communications between the company and the FDA regarding Aduhelm’s approval as well as the decision-making behind the pricing and marketing of the sidelined medicine. 

Editor's note: This story was updated at 3:53 p.m. ET to correctly state that Leqembi is an amyloid beta-directed antibody.