FDA advisors again Alzheimer’s drug Leqembi, paving method for full approval

Alzheimer’s drug Leqembi can be seen in this undated handout picture obtained by Reuters on January 20, 2023.

Eisai | via Reuters

A panel of independent advisers to the Food and Drug Administration unanimously endorsed Friday’s Alzheimer’s drug Leqembi Eisai And biogenicpaving the way for full approval of the treatment this summer.

The advisors voted 6-0 that Eisai’s data demonstrated clinical benefit for patients. The FDA is not required to follow the consultants’ recommendation, but the panel’s vote for Leqembi will strongly support full approval.

The FDA is expected to make a final decision on Leqembi on July 6. The agency’s decision will determine whether Medicare broadly covers the treatment. The seniors program is currently severely limiting Leqembi’s coverage as it was previously approved under an expedited process.

Eisai has set the annual list price for Leqembi at $26,500 per year, meaning most patients can’t afford the treatment without Medicare insurance.

The advisory committee for Leqembi was unusually small on Friday, with only six voting members.

dr Teresa Buracchio, acting chief of the FDA’s neuroscience office, said the committee was smaller than usual because a number of experts withdrew from Friday’s meeting due to conflicts of interest.

“Although this group is small, it has the expertise needed to have an informed discussion on today’s topic,” Buracchio said.

Leqembi is the second Alzheimer’s drug from Eisai and Biogen to be reviewed by the FDA, following the controversial approval of the drug Aduhelm in the summer of 2021.

The drug agency gave accelerated approval to the Aduhelm developed by the two companies, although 10 out of 11 members of the advisory committee concluded that the treatment showed no clinical benefit. A congressional investigation subsequently found that Aduhelm’s approval was “riddled with irregularities.”

Senator Bernie Sanders, chair of the Senate Health Committee, told the Department of Health and Human Services in a letter Wednesday that “The FDA has a special responsibility for maintaining the public’s trust following its improper relationship with Biogen during the review of a previous Alzheimer’s disease by the authority to restore.” Drug, Aduhelm.

FDA sees clinical benefit

Eisai’s study of Leqembi found that the drug slowed cognitive decline by 27% in early-stage Alzheimer’s patients. The antibody is given twice monthly by intravenous infusion. It targets a protein called amyloid, often called plaque, that builds up in the brain and is linked to the disease.

Buracchio informed the panel that the agency considers these results to be clinically meaningful for patients. Several families whose loved ones have Alzheimer’s disease told the panel in the public comments section that Leqembi gave them hope.

Joanne Bridges told the panel that Leqembi helped her husband Jerome continue his daily activities, which improved her life: “Leqembi facilitated the transition from hopelessness to hope for our future – a new life,” Bridges told the panel

“Alzheimer’s is a terrible, debilitating disease for patients and their caregivers,” Bridges said. “The fact that Leqembi can slow the process is a huge step in the fight against the disease and makes life better for those diagnosed with Alzheimer’s.”

Serious Risks

But Leqembi also poses a serious risk of brain swelling and bleeding. During the study, 13% of the patients receiving Leqembi experienced swelling and 14% bleeding.

Swelling and bleeding are usually mild with no obvious symptoms, but these episodes can be life-threatening, according to the FDA.

There were three deaths in the study that may be related to Leqembi, although the FDA was unable to come to any definitive conclusions in its review.

Two patients who died suffered cerebral hemorrhages after receiving the infusions. They were given blood-thinning medication. A third patient who died had an underlying condition called cerebral amyloid angiopathy, in which the blood vessels in the brain are weak, which can cause bleeding.

dr Deniz Erten-Lyons, an FDA official, told the panel that taking blood thinners while being treated with Leqembi could increase the risk of bleeding in the brain.

Several groups expressed strong opposition to the FDA’s approval of Leqembi in the public comments section of Friday’s meeting.

Nina Zeldes of the Public Citizen’s Health Research Group said the FDA had not been presented with any clearly convincing evidence that Leqembi had any clinical benefit. According to Zeldes, serious safety concerns associated with the treatment outweigh the benefits based on the current data.

dr Dona Kim Murphey, a neurologist at Doctors for America, said Eisai’s study was flawed because black Americans, who were at higher risk for Alzheimer’s disease, were grossly underrepresented in the study. Black Americans made up 2.3% of the participants who received Leqembi during the study.

“Given the racially motivated cases of Alzheimer’s and cerebral hemorrhage in black patients and their significant underrepresentation in this study, as a neurologist, I cannot advise this group with lecanemab data,” Murphey said.

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Small panel due to conflicts of interest

Buracchio said the panel was smaller than usual because experts withdrew due to conflicts of interest.

The FDA’s decision on whom to include in Friday’s meeting was influenced by a letter from the Alzheimer’s Association, in which it advocated full approval of Leqembi, Burrachio said. At least one member of the FDA Advisory Committee, Dr. David Weisman, signed this letter.

Weisman was originally barred from attending Friday’s meeting despite serving as the principal investigator for Biogen and Eisai clinical trials on Leqembi and Aduhelm at Abington Neurological Associates.

Weisman then waived the meeting and did not attend.

The incumbent chairman Dr. Robert Alexander was granted an exemption from chairing the panel on Friday, despite holding up to $150,000 worth of stock in companies that compete with Eisai and Biogen. The companies’ names were not named in the FDA disclosure.

Alexander is the scientific director of the Alzheimer’s Prevention Initiative at Banner Alzheimer’s Institute. Banner conducts an Alzheimer’s clinical trial for a competing company, and Alexander earns between $50,000 and $100,000 a year from funding the study.

Bryan Marshall, who heads the office that manages FDA advisory committees, asked the agency to grant Alexander a waiver because he has unique expertise that was “invaluable” to Friday’s meeting.

Medicare coverage, price controversy

Leqembi is technically already available in the U.S. market after it received accelerated approval in January, but very few seniors have access to the expensive treatment because Medicare limits coverage only to people participating in clinical trials. There are no ongoing clinical trials.

As a result, most seniors only have access to Leqembi if they can afford to pay for the drug out of pocket. Leqembi has a list price of $26,500 per year.

Medicare has promised full coverage for Leqembi the same day the FDA fully approves the drug. The Veterans Health Administration already covers the cost of treating veterans.

Senator Sanders said the price for Leqembi was “outrageous” and in a letter ahead of the meeting this week urged HHS Secretary Xavier Becerra to take action to bring the price down.

Sanders said seniors face significant deductible costs, even if Medicare covers Leqembi. The drug’s price would also place a significant financial drain on the seniors’ program, increasing premiums even for people who don’t take the drug, he said.

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