Eisai Anticipates Full Approval of Leqembi as Early as July

Ivan Cheung, chairman and CEO, Eisai Inc./company courtesy

After winning accelerated approval in January, Eisai is anticipating full FDA approval for Alzheimer's drug Leqembi (lecanemab) as early as this summer.

With priority review granted in January, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.

Full approval is a vital step for Leqembi, an anti-amyloid antibody developed with partner Biogen, as it opens the gate for Medicare coverage of the treatment.

The current cost of the drug without said coverage is $26,500 a year. Private insurers often await the decision of the Centers for Medicare & Medicaid Services before making their own coverage clear.

For its part, Eisai has a program in place to provide Leqembi to uninsured patients at no cost and annual cost is expected to come down over time, Cheung told CNBC. 

Chiquita Brooks-LaSure, administrator, CMS, issued a statement on January 6th on behalf of the agency. 

“If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage using the framework we announced last year, under coverage with evidence development, on the same day,” Brooks-LaSure said.    

On a call with reporters Tuesday, Brooks-LaSure said CMS “really wanted to have more information” as to what this class of drugs are going to do.

Cheung told CNBC the Phase III data answer questions about the benefits of Leqembi in slowing cognitive decline and potential side effects including brain hemorrhages, with “a high level of evidence.”

Earlier Detection Critical

The urgency is real for the 100,000 people expected to receive an early Alzheimer’s diagnosis by 2026, which will match the third year of Leqembi's rollout. 

Leqembi targets early-stage patients with mild cognitive impairment or mild dementia. This presents a particular challenge as early diagnosis of Alzheimer's is not easily available today.

To ensure success, CMS also needs to provide reimbursement for expensive diagnostic tests like PET scans, Cheung told CNBC. Because so few treatments exist, physicians are not diagnosing the disease at its earliest stages, he said. 

Also on Friday, a bipartisan group of 20 U.S. senators led by Sen. Susan Collins (R-ME) and Shelley Moore Capito (R-WV), called on Brooks-LaSure and Xavier Becerra, HHS secretary to broaden Medicare coverage for the FDA-approved anti-amyloid antibodies. 

"Unless CMS reconsiders the April 2022 NCD, access to lecanemab and other disease-modifying therapies for Alzheimer's disease will be extremely limited," the senators wrote in their letter. 

The CMS guidance on this class of Alzheimer's drugs was originally put in place in April 2022 and limited coverage of Aduhelm (aducanumab), also developed by Eisai and Biogen, to patients in clinical trials.  

Eisai submitted a supplemental Biologics License Application for traditional approval of Leqembi on January 7th, 2023.