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FDA approves new Alzheimer’s treatment despite risks, unclear benefits

Published

2 years ago

January 6, 2023

Enlarge / MRI of a human brain.

Getty | BSIP

The Food and Drug Administration on Friday granted a fast-tracked approval for a new Alzheimer’s disease treatment, which may slightly slow the progression of cognitive decline in the disease’s early stages, but also raises risks of brain bleeds and swelling.

The treatment—lecanemab, brand name Leqemb, made by pharmaceutical companies Eisai and Biogen—is an intravenous monoclonal antibody that targets amyloid-beta proteins, which accumulate in plaques in the brains of people with Alzheimer’s. Researchers have not yet conclusively determined if amyloid plaques are a root cause of the disease, nor whether clearing them can significantly slow or halt cognitive decline.

The FDA’s approval of lecanemab is via an accelerated pathway, which uses “a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.” In this case, the surrogate endpoint was lecanemab’s ability to reduce amyloid beta plaques in the brains of Alzheimer’s patients.

Uncertain efficacy

But, the significance of that and the drug’s efficacy are still uncertain. In a Phase III clinical trial, published this week in the New England Journal of Medicine, treatment with lecanemab over 18 months only slightly slowed cognitive decline in patients with early Alzheimer’s. The trial included 1,795 participants—898 were assigned to receive lecanemab and 897 were assigned a placebo. Their cognitive abilities were assessed using an 18-point scale from an established clinical test for dementia. At the start of the trial, both groups (treatment and placebo) has a baseline score of about 3.2 on the test. After the 18-month trial, the lecanemab treatment group’s score fell by 1.21 points, while the placebo group’s fell by 1.66 points—a 0.45-point difference that amounts to a 27 percent slower decline in the treatment group.

It’s unclear if that change is meaningful. Dr. Madhav Thambisetty, a neurologist and a senior investigator at the National Institute on Aging who spoke with The New York Times, said that the drug’s ability to clear amyloid plaques was “exciting,” from the perspective of a scientist. But, “from the perspective of a physician caring for Alzheimer’s patients, the difference between lecanemab and placebo is well below what is considered to be a clinically meaningful treatment effect.”

The researchers behind the clinical trial noted in their conclusion that “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”

Safety concerns

Meanwhile, the treatment has raised safety concerns, particularly amid reports that three patients given the drug have died from brain swelling and bleeding. That includes a 65-year-old woman with early stage cognitive decline who died of a massive brain hemorrhage. Rudolph Castellani, a Northwestern Medicine neuropathologist who studies Alzheimer’s and conducted an autopsy on the woman at the request of her husband, told Science last November that he believed that the drug weakened the woman’s blood vessels, which then burst from a common treatment for blood clots after she had a stroke.

“It was a one-two punch,” Castellani told Science, which first reported the death. “There’s zero doubt in my mind that this is a treatment-caused illness and death. If the patient hadn’t been on lecanemab she would be alive today.”

A report of the woman’s death was also published this week in the New England Journal of Medicine.

Lecanemab’s prescribing information includes warnings and cautions about brain bleeding and swelling, and the use of blood thinners.

The FDA’s approval comes just a week after lawmakers released the results of an 18-month Congressional investigation into the agency’s much-criticized approval of a similar Alzheimer’s drug, Aduhelm. Data on that amyloid-targeting antibody therapy was even less conclusive than lecanamab’s, and the FDA granted approval over objections from its external advisory panel and internal experts.

Irregularities

The Congressional investigation found the FDA’s approval process “rife with irregularities” and “inappropriate” communications between FDA and Aduhelm’s maker, Biogen. The report also blasted Biogen for setting “an unjustifiably high price” of $56,000 a year for Aduhelm.

“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm,” Energy and Commerce Committee incoming Ranking Member Frank Pallone, Jr. (D-NJ), said at the time.

Following the approval of lecanemab, Pallone released a statement saying: “I’m hopeful lecanemab will live up to its promise of slowing the progression of Alzheimer’s disease for patients and their loved ones. I’m also hopeful Eisai and Biogen have learned from past mistakes and will price lecanemab fairly to ensure patients have equitable access to this drug.

In a press release Friday afternoon, Eisai announced that it is pricing lecanemab at $26,500 for a year’s supply. That is above the range that the Institute for Clinical and Economic Review estimated would make the drug cost-effective, which the analysis group pegged at between $8,500 and $20,600 for a year’s worth of treatment.

It’s unclear if Medicare will cover lecanemab, which will dramatically influence its marketability. Medicare strictly limited coverage of Aduhelm, due to the high price, lack of evidence of benefit, and risks. Only Medicare beneficiaries in clinical trials have coverage for the price of Aduhelm, which has since been cut to $28,200 for a year’s supply.

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Japan’s SoftBank returns to profit after gains at Vision Fund and other investments

Published

6 hours ago

November 12, 2024

Anne Joseph

TOKYO (AP) — Japanese technology group SoftBank swung back to profitability in the July-September quarter, boosted by positive results in its Vision Fund investments.

Tokyo-based SoftBank Group Corp. reported Tuesday a fiscal second quarter profit of nearly 1.18 trillion yen ($7.7 billion), compared with a 931 billion yen loss in the year-earlier period.

Quarterly sales edged up about 6% to nearly 1.77 trillion yen ($11.5 billion).

SoftBank credited income from royalties and licensing related to its holdings in Arm, a computer chip-designing company, whose business spans smartphones, data centers, networking equipment, automotive, consumer electronic devices, and AI applications.

The results were also helped by the absence of losses related to SoftBank’s investment in office-space sharing venture WeWork, which hit the previous fiscal year.

WeWork, which filed for Chapter 11 bankruptcy protection in 2023, emerged from Chapter 11 in June.

SoftBank has benefitted in recent months from rising share prices in some investment, such as U.S.-based e-commerce company Coupang, Chinese mobility provider DiDi Global and Bytedance, the Chinese developer of TikTok.

SoftBank’s financial results tend to swing wildly, partly because of its sprawling investment portfolio that includes search engine Yahoo, Chinese retailer Alibaba, and artificial intelligence company Nvidia.

SoftBank makes investments in a variety of companies that it groups together in a series of Vision Funds.

The company’s founder, Masayoshi Son, is a pioneer in technology investment in Japan. SoftBank Group does not give earnings forecasts.

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Business

Trump campaign promises unlikely to harm entrepreneurship: Shopify CFO

Published

6 hours ago

November 12, 2024

Anne Joseph

Shopify Inc. executives brushed off concerns that incoming U.S. President Donald Trump will be a major detriment to many of the company’s merchants.

“There’s nothing in what we’ve heard from Trump, nor would there have been anything from (Democratic candidate) Kamala (Harris), which we think impacts the overall state of new business formation and entrepreneurship,” Shopify’s chief financial officer Jeff Hoffmeister told analysts on a call Tuesday.

“We still feel really good about all the merchants out there, all the entrepreneurs that want to start new businesses and that’s obviously not going to change with the administration.”

Hoffmeister’s comments come a week after Trump, a Republican businessman, trounced Harris in an election that will soon return him to the Oval Office.

On the campaign trail, he threatened to impose tariffs of 60 per cent on imports from China and roughly 10 per cent to 20 per cent on goods from all other countries.

If the president-elect makes good on the promise, many worry the cost of operating will soar for companies, including customers of Shopify, which sells e-commerce software to small businesses but also brands as big as Kylie Cosmetics and Victoria’s Secret.

These merchants may feel they have no choice but to pass on the increases to customers, perhaps sparking more inflation.

If Trump’s tariffs do come to fruition, Shopify’s president Harley Finkelstein pointed out China is “not a huge area” for Shopify.

However, “we can’t anticipate what every presidential administration is going to do,” he cautioned.

He likened the uncertainty facing the business community to the COVID-19 pandemic where Shopify had to help companies migrate online.

“Our job is no matter what comes the way of our merchants, we provide them with tools and service and support for them to navigate it really well,” he said.

Finkelstein was questioned about the forthcoming U.S. leadership change on a call meant to delve into Shopify’s latest earnings, which sent shares soaring 27 per cent to $158.63 shortly after Tuesday’s market open.

The Ottawa-based company, which keeps its books in U.S. dollars, reported US$828 million in net income for its third quarter, up from US$718 million in the same quarter last year, as its revenue rose 26 per cent.

Revenue for the period ended Sept. 30 totalled US$2.16 billion, up from US$1.71 billion a year earlier.

Subscription solutions revenue reached US$610 million, up from US$486 million in the same quarter last year.

Merchant solutions revenue amounted to US$1.55 billion, up from US$1.23 billion.

Shopify’s net income excluding the impact of equity investments totalled US$344 million for the quarter, up from US$173 million in the same quarter last year.

Daniel Chan, a TD Cowen analyst, said the results show Shopify has a leadership position in the e-commerce world and “a continued ability to gain market share.”

In its outlook for its fourth quarter of 2024, the company said it expects revenue to grow at a mid-to-high-twenties percentage rate on a year-over-year basis.

“Q4 guidance suggests Shopify will finish the year strong, with better-than-expected revenue growth and operating margin,” Chan pointed out in a note to investors.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:SHOP)

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RioCan cuts nearly 10 per cent staff in efficiency push as condo market slows

Published

6 hours ago

November 12, 2024

Anne Joseph

TORONTO – RioCan Real Estate Investment Trust says it has cut almost 10 per cent of its staff as it deals with a slowdown in the condo market and overall pushes for greater efficiency.

The company says the cuts, which amount to around 60 employees based on its last annual filing, will mean about $9 million in restructuring charges and should translate to about $8 million in annualized cash savings.

The job cuts come as RioCan and others scale back condo development plans as the market softens, but chief executive Jonathan Gitlin says the reductions were from a companywide efficiency effort.

RioCan says it doesn’t plan to start any new construction of mixed-use properties this year and well into 2025 as it adjusts to the shifting market demand.

The company reported a net income of $96.9 million in the third quarter, up from a loss of $73.5 million last year, as it saw a $159 million boost from a favourable change in the fair value of investment properties.

RioCan reported what it says is a record-breaking 97.8 per cent occupancy rate in the quarter including retail committed occupancy of 98.6 per cent.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:REI.UN)

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