U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, albeit with potential safety risks that patients and their doctors will have to carefully weigh.
The drug, Leqembi, is the first that’s been convincingly shown to slow the decline in memory and thinking that defines Alzheimer’s by targeting the disease’s underlying biology. The U.S. Food and Drug Administration (FDA) approved it for patients with Alzheimer’s, specifically those with mild or early-stage disease.
Leqembi, from Japan’s Eisai and its U.S. partner Biogen, is a rare success in a field accustomed to failed experimental treatments for the incurable condition. The delay in cognitive decline brought about by the drug likely amounts to just several months, but some experts say it could still meaningfully improve people’s lives.
“This drug is not a cure. It doesn’t stop people from getting worse, but it does measurably slow the progression of the disease,” said Dr. Joy Snider, a neurologist at Washington University in St. Louis. “That might mean someone could have an extra six months to a year of being able to drive.”
Snider stressed that the medicine comes with downsides, including the need for twice-a-month infusions and possible side effects like brain swelling.
A picture of a human brain is taken by PET scan at a hospital in France in January 2019. (Fred Tanneau/AFP/Getty Images)
The FDA approval came via its accelerated pathway, which allows drugs to launch based on early results before they’re confirmed to benefit patients. The agency’s use of that shortcut approach has come under increasing scrutiny from government watchdogs and congressional investigators.
Last week, a congressional report found that FDA’s approval of a similar Alzheimer’s drug called Aduhelm — also from Biogen and Eisai — was “rife with irregularities,” including a number of meetings with drug company staffers that went undocumented.
Scrutiny of the new drug, known chemically as lecanemab, will likely mean most patients won’t start receiving it for months, as insurers decide whether and how to cover it.
The drug will cost about $26,500 US ($35,613 Cdn) for a typical year’s worth of treatment. Eisai said the price reflects the drug’s benefit in terms of improved quality of life, reduced burdens for caregivers and other factors. The company pegged its value at over $37,000 US ($49,725 Cdn) per year but said it priced it lower to reduce costs for patients and insurers. An independent group that assesses drug value recently said the drug would have to be priced below $20,600 US ($27,684 Cdn) per year to be cost-effective.
Alzheimer’s didn’t stop him from earning a university degree
After being diagnosed with Alzheimer’s at the age of 80, Ron Robert enrolled at King’s University College in London, Ont., to challenge his mind and how society treats people living with the disease.
Some six million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and daily tasks.
The FDA’s approval was based on one mid-stage study in 800 people with early signs of Alzheimer’s who were still able to live independently or with minimal assistance.
Since then, Eisai has published the results of a larger 1,800-patient study that the FDA will review to confirm the drug’s benefit, paving the way for full approval later this year.
Today, we approved a new medication for the treatment of Alzheimer’s disease, the second of a new category of medications approved for Alzheimer’s that target the fundamental pathophysiology of the disease. <a href=”https://t.co/ZXJCUuTYPk”>https://t.co/ZXJCUuTYPk</a> <a href=”https://t.co/TV36k6CO6K”>pic.twitter.com/TV36k6CO6K</a>
The larger study tracked patients’ results on an 18-point scale that measures memory, judgment and other cognitive abilities. Doctors compile the rating from interviews with the patient and a close contact. After 18 months, patients receiving Leqembi declined more slowly — a difference of less than half a point on the scale — than patients who received a dummy infusion. The delay amounted to just over five months.
There is little consensus on whether that difference translates into real benefits for patients, such as greater independence.
“Most patients won’t notice the difference,” said Dr. Matthew Schrag, a neurology researcher at Vanderbilt University. “This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”
Schrag and some other researchers believe a meaningful improvement would require at least a difference of one full point on the 18-point scale.
‘I have pretty serious doubts’
Leqembi works by clearing a sticky brain protein called amyloid that’s one hallmark of Alzheimer’s. But it’s not clear exactly what causes the disease. A string of other amyloid-targeting drugs have failed and many researchers now think combination treatments will be needed.
Aduhelm, the similar drug, was marred by controversy over its effectiveness.
The FDA approved that drug in 2021 against the advice of the agency’s own outside experts. Doctors hesitated to prescribe the drug and insurers restricted coverage.
Debating the risks, benefits of a controversial Alzheimer drug
There’s debate over whether Canada should follow the U.S.’s lead and approve a controversial drug to treat Alzheimer’s, despite concerns Aducanumab isn’t effective and can be harmful. But the uncertainty isn’t stopping some patients from wanting to try the medication.
The FDA did not consult the same expert panel before approving Leqembi.
While there’s “less drama,” surrounding the new drug, Schrag said many of the same concerns apply.
“Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience?” he asked. “I have pretty serious doubts.”
About 13 per cent of patients in Eisai’s study had swelling of the brain and 17 per cent had small brain bleeds, side effects seen with earlier amyloid-targeting medications. In most cases those problems didn’t cause symptoms, which can include dizziness and vision problems.
Also, several Leqembi users died while taking the drug, including two who were on blood-thinning medications. Eisai has said the deaths can’t be attributed to the drug. The FDA label warns doctors to use caution if they prescribe Leqembi to patients on blood thinners.
Insurers are likely to only cover the drug for people like those in the company study — patients with mild symptoms and confirmation of amyloid buildup. That typically requires expensive brain scans. A separate type of scan will be needed to periodically monitor for brain swelling and bleeding.
Medicare question
A key question in the drug’s rollout will be the coverage decision by Medicare, the federal health plan that covers 60 million seniors and other Americans. The agency severely restricted coverage of Aduhelm, essentially wiping out its U.S. market and prompting Biogen to abandon marketing plans for the drug.
Eisai executives said they have already spent months discussing their drug’s data with Medicare officials. Coverage isn’t expected until after the FDA confirms the drug’s benefit, likely later this year.
“Once we have a Medicare decision, then we can truly launch the drug across the country,” said Eisai’s U.S. CEO, Ivan Cheung.
Dr. Sultan Darvesh of Dalhousie University says they have created a molecule to detect the disease in the brain.
Betsy Groves, 73, of Cambridge, Mass., was diagnosed with Alzheimer’s in 2021. A former lecturer at Harvard’s school of education, she noticed she was having trouble remembering some student names and answering questions.
Her initial diagnosis, based on a cognitive examination, was later confirmed by a positive test for amyloid.
Groves says she is “more than willing” to try Leqembi, despite potential side effects and the need for infusions.
“For me, the minute that drug comes on the market — and I get my doctor’s approval — I’m going to take it,” Groves said.
MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.
The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.
The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.
Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.
On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.
Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.
This report by The Canadian Press was first published Sept. 12, 2024.
Dollarama Inc.’s food aisles may have expanded far beyond sweet treats or piles of gum by the checkout counter in recent years, but its chief executive maintains his company is “not in the grocery business,” even if it’s keeping an eye on the sector.
“It’s just one small part of our store,” Neil Rossy told analysts on a Wednesday call, where he was questioned about the company’s food merchandise and rivals playing in the same space.
“We will keep an eye on all retailers — like all retailers keep an eye on us — to make sure that we’re competitive and we understand what’s out there.”
Over the last decade and as consumers have more recently sought deals, Dollarama’s food merchandise has expanded to include bread and pantry staples like cereal, rice and pasta sold at prices on par or below supermarkets.
However, the competition in the discount segment of the market Dollarama operates in intensified recently when the country’s biggest grocery chain began piloting a new ultra-discount store.
The No Name stores being tested by Loblaw Cos. Ltd. in Windsor, St. Catharines and Brockville, Ont., are billed as 20 per cent cheaper than discount retail competitors including No Frills. The grocery giant is able to offer such cost savings by relying on a smaller store footprint, fewer chilled products and a hearty range of No Name merchandise.
Though Rossy brushed off notions that his company is a supermarket challenger, grocers aren’t off his radar.
“All retailers in Canada are realistic about the fact that everyone is everyone’s competition on any given item or category,” he said.
Rossy declined to reveal how much of the chain’s sales would overlap with Loblaw or the food category, arguing the vast variety of items Dollarama sells is its strength rather than its grocery products alone.
“What makes Dollarama Dollarama is a very wide assortment of different departments that somewhat represent the old five-and-dime local convenience store,” he said.
The breadth of Dollarama’s offerings helped carry the company to a second-quarter profit of $285.9 million, up from $245.8 million in the same quarter last year as its sales rose 7.4 per cent.
The retailer said Wednesday the profit amounted to $1.02 per diluted share for the 13-week period ended July 28, up from 86 cents per diluted share a year earlier.
The period the quarter covers includes the start of summer, when Rossy said the weather was “terrible.”
“The weather got slightly better towards the end of the summer and our sales certainly increased, but not enough to make up for the season’s horrible start,” he said.
Sales totalled $1.56 billion for the quarter, up from $1.46 billion in the same quarter last year.
Comparable store sales, a key metric for retailers, increased 4.7 per cent, while the average transaction was down2.2 per cent and traffic was up seven per cent, RBC analyst Irene Nattel pointed out.
She told investors in a note that the numbers reflect “solid demand as cautious consumers focus on core consumables and everyday essentials.”
Analysts have attributed such behaviour to interest rates that have been slow to drop and high prices of key consumer goods, which are weighing on household budgets.
To cope, many Canadians have spent more time seeking deals, trading down to more affordable brands and forgoing small luxuries they would treat themselves to in better economic times.
“When people feel squeezed, they tend to shy away from discretionary, focus on the basics,” Rossy said. “When people are feeling good about their wallet, they tend to be more lax about the basics and more willing to spend on discretionary.”
The current economic situation has drawn in not just the average Canadian looking to save a buck or two, but also wealthier consumers.
“When the entire economy is feeling slightly squeezed, we get more consumers who might not have to or want to shop at a Dollarama generally or who enjoy shopping at a Dollarama but have the luxury of not having to worry about the price in some other store that they happen to be standing in that has those goods,” Rossy said.
“Well, when times are tougher, they’ll consider the extra five minutes to go to the store next door.”
This report by The Canadian Press was first published Sept. 11, 2024.
TORONTO – The U.S. Consumer Financial Protection Bureau has ordered TD Bank Group to pay US$28 million for repeatedly sharing inaccurate, negative information about its customers to consumer reporting companies.
The agency says TD has to pay US$7.76 million in total to tens of thousands of victims of its illegal actions, along with a US$20 million civil penalty.
It says TD shared information that contained systemic errors about credit card and bank deposit accounts to consumer reporting companies, which can include credit reports as well as screening reports for tenants and employees and other background checks.
CFPB director Rohit Chopra says in a statement that TD threatened the consumer reports of customers with fraudulent information then “barely lifted a finger to fix it,” and that regulators will need to “focus major attention” on TD Bank to change its course.
TD says in a statement it self-identified these issues and proactively worked to improve its practices, and that it is committed to delivering on its responsibilities to its customers.
The bank also faces scrutiny in the U.S. over its anti-money laundering program where it expects to pay more than US$3 billion in monetary penalties to resolve.
This report by The Canadian Press was first published Sept. 11, 2024.
