Eli Lilly’s Donanemab Gains Crucial Approval from Federal Health Panel

Eli Lilly’s Donanemab Gains Crucial Approval
Eli Lilly’s Donanemab Gains Crucial Approval. Credit | Getty images

United States – An independent federal panel on Monday approved recommending Eli Lilly’s new drug, which is still in contemplation in bids to possibly mitigate Alzheimer’s ailment.

A couple of days ago, more specifically on Monday, one of the FDA’s most important committees – Peripheral and Central Nervous System Drugs Advisory Committee – met to discuss Eli Lilly’s donanemab, as reported by The Hills.

The voting members of the committee were required to vote on the question regarding the clinical benefit, “Based on the available data, does it reveal that donanemab is effective for the treatment of Alzheimer’s disease in the population with mild cognitive impairment and mild dementia included in the clinical trials?”

The drug functions accordingly by interacting with amyloid plaques for their removal, as they are considered toxic and cause cell death.

Mechanism of Action and Clinical Trial Results

It has also been noted that those patients benefiting from Donepezil experienced a 22 percent reduction in disease progression when assessed using the Integrated Alzheimer’s Disease Rating Scale (ADRs) compared to the placebo control group within the same period.

When asked, ‘Does the data available favor the use of donanemab as a treatment in mild dementia?’, ten of the eleven voting members of the committee voted in the affirmative. Some of them pointed out that they voted yes because there was a certain tolerance level of risk-adjusted to the data.

Diversity Concerns and Mixed Reactions

Still, some members noted that they have little to no Black or Hispanic people participating in the trial.

In records provided to the committee, the representations of Eli Lilly also revealed that when assessed by Clinical Dementia Rating Scale—Sum of Boxes scoring system, individuals who took the drug had a 29 percent reduced rate of disease progression than the placebo group. This was confirmed after seventy-six weeks of administration of the drug.

“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.

“Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety,” Pike added. “This will lead to possibilities for combination therapies that address the complexity of the disease.”

Another detailed source of opposition came from a progressive consumer rights organization called Public Citizen, which was against the approval of Donanemab after the committee vote. In a testimonial that the group filed, they claimed that the results showed in the study, especially the one done using the iADRS scale, pointed towards the fact that the drug was not going to be ‘clinically meaningful.’

Opposition from Public Citizen

“It was a very disappointing advisory committee meeting. The issue wasn’t what the prescribing information could contain about the potential risks and benefits of donanemab but rather whether the drug should be approved in the first place,” said Robert Steinbrook, director of Public Citizen’s Health Research Group.

The FDA has cleared two other drugs for Alzheimer’s in recent times, though one of these is off the market now. In 2021, the agency approved a new drug sold by the company Biogen called Aduhelm, which is the first Alzheimer’s solution cleared in two decades. But there was never proof that the drug, known as aducanumab, did what it was supposed to do, and in the end, Biogen let go of Aduhelm this year, as reported by The Hills.

This past year, the FDA approved Leqemli, another Biogen drug that just half-slowed the progression of Alzheimer’s.