The Alzheimer’s drug Leqembi is seen in this undated handout image obtained by Reuters on Jan. 20, 2023.

Eisai | via Reuters

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

The advisors voted 6-0 that the Eisai data demonstrated clinical benefit for patients. The FDA doesn’t have to follow the advisors’ recommendations, but the panel’s vote for Leqembi will weigh heavily in favor of full approval.

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

Eisai set the annual list price of Leqembi at $26,500 per year, meaning most patients cannot afford the treatment without Medicare coverage.

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

Dr. Teresa Buracchio, acting head of the FDA’s Office of Neuroscience, said the smaller-than-usual committee was the result of a number of experts declining to meet Friday because of conflicts of interest.

“Although this group is small, it contains the appropriate expertise necessary to have a thorough discussion of today’s topic,” Buracchio said.

Leqembi is the second Alzheimer’s treatment from Eisai and Biogen to come under FDA review after the controversial summer 2021 approval of Aduhelm.

The medicines regulator granted fast-track approval Aduhelm, developed by the two companies, even though 10 of the 11 advisory committee members concluded that the treatment did not demonstrate clinical benefit. A congressional investigation subsequently found that the approval of Aduhelm was “fraught with irregularities”.

Sen. Bernie Sanders, chairman of the Senate Health Committee, said in a letter to the Department of Health and Human Services on Wednesday that “the FDA has a special responsibility to restore public trust after its inappropriate relationship with Biogen during the previous Alzheimer’s review.” drug, Aduhelm.”

FDA sees clinical benefit

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

Buracchio told the panel that the agency considers these results to be clinically relevant to patients. Several families who have loved ones diagnosed with Alzheimer’s disease told the panel during the public comment section that Leqembi has given them hope.

Joanne Bridges told the jury that Leqembi helped her husband Jerome continue with his daily activities, which improved their lives: “Going from hopelessness to hope for our future was possible because of Leqembi – a new breath of life,” Bridges told the jury.

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

Serious risks

However, Leqembi also carries a serious risk of brain swelling and bleeding. During the study, 13% of patients receiving Leqembi had swelling and 14% had 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 have been related to Leqembi, although the FDA was unable to draw definitive conclusions in its review.

The two patients who died suffered cerebral hemorrhage after the infusions. They were given blood thinners. The third patient who died had an underlying condition called cerebral amyloid angiopathy, in which the blood vessels in the brain are weak, which can lead to bleeding.

Dr. Deniz Erten-Lyons, an FDA official, told the panel that taking blood thinners during treatment with Leqembi may increase the risk of brain bleeds.

Several groups voiced strong opposition to Leqembi’s FDA approval during Friday’s public comment section of the meeting.

Nina Zeldes s Public citizenThe Health Research Group said the FDA had not been presented with clear convincing evidence that Leqembi has a clinical benefit. Zeldes said the serious safety concerns associated with the treatment outweigh the benefits based on the current data.

Dr. Dona Kim Murphey, neurologist s Doctors for America, said Eisai’s study was flawed because black Americans, who are at higher risk for Alzheimer’s disease, were significantly underrepresented in the trial. Black Americans represented 2.3% of participants who received Leqembi during the study.

“Due to the racial bias of Alzheimer’s disease and brain hemorrhage in blacks and their significant underrepresentation in this study, I cannot, as a neurologist, advise this group with the lecanemab data,” Murphey said.

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Small panel due to conflict of interest

Buracchio said the panel was smaller than usual due to experts recusing themselves due to conflicts of interest.

The FDA’s decision on who to include in Friday’s meeting was influenced by a letter from the FDA Alzheimer’s Association who advocated for Leqembi’s full consent, Burrachio said. At least one FDA advisory board member, Dr. David Weisman, signed this letter.

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

Weisman subsequently revoked himself from the meeting and did not participate.

The acting chairman was Dr. Robert Alexander granted an exception to lead the panel on Friday despite holding up to $150,000 worth of stock in companies that compete with Eisai and Biogen. The FDA release did not name the companies.

Alexander is the Senior Scientist of the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute. Banner is conducting a clinical trial of Alzheimer’s disease for a competing firm, and Alexander receives $50,000 to $100,000 a year in salary from funds to support the study.

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

Medicare coverage, the price controversy

Leqembi is technically already available in the US market after receiving a fast transfer approval in January, but very few seniors have access to expensive treatment because Medicare limits coverage to only those participating in clinical trials. There are no ongoing clinical trials.

As a result, most seniors can only access 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 broadly promised this Cover Leqembi same day FDA fully approves drug. The Veterans Health Administration already covers treatment for veterans.

Sen. Sanders said the Leqembi price is “disproportionate” and called on HHS Secretary Xavier Becerra to take action to lower the price in a letter ahead of a meeting this week.

Sanders said seniors will face significant out-of-pocket costs even if Medicare covers Leqembi. According to him, the price of the medicine would also put a significant financial burden on the program for seniors and would increase insurance premiums even for people who do not take the medicine.

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