Pictured: Three side-by-side scans of a human brain/iStock, semnic
On Friday, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-0 in support of the full approval of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.
This unanimous show of support signals that the FDA is likely to grant the drug full approval on or before July 6. The FDA is not obligated to follow the recommendations of its advisory committees, but it usually does.
The adcomm’s decision Friday to recommend Leqembi’s approval comes as no surprise. On Wednesday, the FDA released its own briefing documents that showed agency staff believed the trial, dubbed Study 301 (CLARITY AD), likely verified the clinical benefit of lecanemab for the treatment of AD.
“I thought the evidence for clinical benefit was very clear and very robust,” said Merit Cudkowicz, committee member and chief of the neurology department at Massachusetts General Hospital. “Most of our questions were around the safety and the subgroups, but this [study] was robust on the primary and key secondary [endpoints]. . . . I didn’t have any doubt about the efficacy.”
Last week, the Centers for Medicare & Medicaid Services elaborated on its intentions to broaden coverage for new Alzheimer’s drugs, such as Biogen and Eisai’s Leqembi, if they receive full approval from the FDA. CMS indicated that it is ready to provide coverage for anyone with Medicare Part B who meets the criteria upon traditional FDA approval.
Original story, published June 8:
FDA Indicates Potential Full Approval for Eisai & Biogen’s Leqembi Ahead of Adcomm
The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval.
The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD?
But it appears the agency may have already decided for itself.
Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” which included a reduction in cognitive decline.
The agency added that the main safety signals—amyloid-related imaging abnormalities (ARIA), cerebral hemorrhage and infusion-related reactions and hypersensitivity—are not greater than the benefit and “do not appear to preclude traditional approval of lecanemab.”
A full approval would replace the conditional approval the agency granted the drug in January, when it became the second drug the FDA had approved to treat Alzheimer’s in two years. At the time, there was an open question as to whether Medicare would cover Leqembi upon full approval, as the Centers for Medicare & Medicaid Services (CMS) previously stated it would only cover the cost for patients enrolled in clinical trials of the drug.
This question was answered last Thursday, when CMS Administrator Chiquita Brooks-LaSure announced Medicare would pay for new Alzheimer’s drugs after the FDA granted them full approval. The coverage comes with one condition: physicians will be required to collect data about how well the drugs perform in their patients.
This marks the first time the CMS has required physicians to record this kind of information. When doctors prescribe Leqembi, they will register the patient in a government registry to keep track of the patient’s symptoms and overall health.
The same day the CMS announced its decision, the Alzheimer's Association published a press release criticizing the requirement for physicians.
“We continue to believe that registry as a condition of coverage is an unnecessary barrier,” the organization stated. “Registries are important tools to gather much-needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of an FDA-approved treatment.”
Rosemary Scott is an editor at BioSpace, focusing on the job market and career development for professionals in the life sciences. You can reach her at firstname.lastname@example.org and on LinkedIn.