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Wednesday, July 28, 2021

Cleveland Clinic, Mount Sinai Won’t Give Biogen’s New Alzheimer’s Drug

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A pair of large hospitals are declining to administer

Biogen Inc.’s

BIIB -6.79%

new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month.

The Cleveland Clinic and Mount Sinai Health System in New York said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.

The Cleveland Clinic won’t carry the drug in its pharmacy or provide infusions of it to patients following a review of available scientific evidence by a multidisciplinary panel of experts, a hospital spokeswoman said.

Cleveland Clinic doctors, the spokeswoman said, can still prescribe the medicine, but patients will have to receive their infusions at an outside facility.

The FDA approved Aduhelm in June based on two large but inconclusive studies.



Photo:

Jessica Rinaldi/Press Pool

Aduhelm is given with a monthly infusion, typically at an outpatient medical center. Biogen priced the drug at $56,000 a year, though one health researcher said it will probably cost more for a typical patient.

“Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” the Cleveland Clinic said. “However, we support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients.”

A Biogen spokeswoman said that patients denied access to Aduhelm should contact Biogen for help.

“Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s disease may reportedly not be able to access Aduhelm at some facilities,” the spokeswoman said. “Biogen continues to stand 100% behind Aduhelm and the clinical data that supported approval.”

The New York Times earlier reported the hospital systems weren’t going to administer Aduhelm to patients.

In June, the FDA approved Aduhelm based on two large but inconclusive studies of its effect in slowing cognitive decline in people with mild Alzheimer’s symptoms.

The FDA issued the approval using a regulatory mechanism that allows for drugs to be cleared before they are definitively proven effective, saying the drug was reasonably likely to provide a benefit by reducing levels of a sticky protein called amyloid from the brain.

Cleveland Clinic doctors may still prescribe Aduhelm, but patients will have to receive their infusions at an outside facility.



Photo:

aaron josefczyk/Reuters

The FDA approval was made over the objections of some of its own statisticians and members of an outside committee of experts convened by the agency to provide advice on the drug. Three of the outside advisers resigned from the committee in protest of the FDA’s decision.

The FDA subsequently narrowed its recommendation for who should get the drug, to Alzheimer’s patients in the early stage of the disease.

Acting FDA Commissioner

Janet Woodcock

earlier this month requested an investigation by an internal government oversight agency into interactions between FDA staff and Biogen during the review process leading up to the approval and whether there were any communications inconsistent with FDA policies.

A Mount Sinai spokeswoman said the hospital system won’t infuse Aduhelm while its experts continue to deliberate over the drug and await the findings of the government investigation into the FDA’s interactions with Biogen.

Before Mount Sinai reconsiders administering the drug, it wants to be assured the investigation affirms the integrity of the agency’s interactions with Biogen and to see the agency’s accelerated approval of Aduhelm is reaffirmed, the spokeswoman said.

In addition, the hospital system is awaiting the writing of “best practices” guidelines for Aduhelm by its own experts, as well as a standard review necessary for adding Aduhelm to its formulary of available drugs, the spokeswoman said.

“Only after all these are in place will we reconsider,” the spokeswoman said. “These conditions must be met before we take up the question of infusion on our campuses.”

Write to Joseph Walker at joseph.walker@wsj.com

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