The Food and Drug Administration on Thursday granted full approval to Eisai’s and Biogen’s Alzheimer’s drug Leqembi, or lecanemab, marking the first drug in the class to receive the designation.
Nationally, Alzheimer’s disease affects an estimated 6.7 million people aged 65 and older. Black people are twice as likely to develop dementia than white people, and Hispanics are 1.5 times more likely.
The monoclonal antibody targets amyloid beta plaque buildup in the brain, and is approved for people in the early stages of the disease. The label also recommends genetic testing to measure the risk of side effects and to use caution if a patient is on blood thinners.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the FDA’s Office of Neuroscience within the Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
The widely expected decision follows a unanimous 6–0 recommendation from FDA’s external advisory committee in May, and signals a new era in Alzheimer’s research and treatment. The FDA granted the drug accelerated approval in January, which required the companies to submit further proof of the drug’s clinical benefit.
The approval is also a chance at public redemption for Biogen and Eisai, which launched another controversial and expensive Alzheimer’s drug Aduhelm, or aducanumab, in 2021.
The FDA’s surprise decision to grant Aduhelm accelerated approval came over the objections of its advisory committee and prompted the Centers for Medicare and Medicaid Services to limit coverage of the drug class. It also spawned multiple federal investigations and led to Biogen CEO Michel Vounatsos’ resignation.
So far, the outlook is better for Leqembi. The drug’s steep price still carries concerns for Medicare’s financial sustainability, but at $26,500 per year is half that of Aduhelm’s initial $56,000 price tag.
Full approval will also dramatically broaden Medicare’s coverage from clinical trial participants to patients of doctors participating in a data registry — although questions remain about a free registry that CMS is in the process of creating.
The drug also has a risk of severe side effects, including swelling and bleeding in the brain. But the evidence behind Leqembi is much stronger than it was for Aduhelm, even though some advocacy groups like Public Citizen say the data are overblown.
Lawmakers on both sides of the aisle have been agitating for CMS to broaden coverage for the drug class, citing the desperate need among the Alzheimer’s community.
Republicans have been especially critical. House Energy and Commerce Chair Cathy McMorris Rodgers, R-Wash., said in a statement Wednesday that full approval means “there will be no excuses for CMS to effectively deny coverage to Americans in need.”
CMS is also revisiting coverage limits on PET scans needed to monitor progress and side effects in Leqembi patients. Medicare currently covers just one PET scan per each dementia patient’s lifetime. CMS said it expects to release a new decision “soon.”
Alzheimer’s Association President and CEO Joanne Pike said that coverage issues would be a “number-one priority” for the group going forward.
“People living with this fatal disease deserve the opportunity to discuss and choose, with their doctor and family, whether an FDA-approved treatment is right for them,” she said.
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