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National

The Food and Drug Administration on Friday granted fast-track approval to a new Alzheimer's drug that clinical trials showed can slow the progression of the disease.

Why it matters: Lecanemab, developed by Japanese drugmaker Eisai and Biogen, is the first treatment shown to delay cognitive decline from Alzheimer's — which affects over six million people in the U.S.

Eisai published its clinical trial results in November, confirming that lecanemab — which will be marketed as Leqembi — managed to moderately slow onset of the disease. But there were safety concerns, with some patients experiencing "serious adverse events," prompting investigators to say further studies may be needed.

The drugmaker said that it plans to submit an application for full FDA approval by the end of March.

State of play: The agency reiterated the drug's label recommendations, saying that the treatment should be "initiated in patients with mild cognitive impairment or mild dementia stage of disease."

The big picture: A new Alzheimer's drug could cost the U.S. health system billions every year.

Eisai said that lecanemab's annual price will be $26,500. A cost-effective price would be between $8,500 and $20,600 a year, the Institute for Clinical and Economic Review said last month.

The company noted that it is looking into lessening the drug's dosing frequency potentially from biweekly to monthly, which could lower the annual cost by half. 

Data for another promising Alzheimer's treatment by Eli Lilly that is similar to lecanemab is expected midyear.

What we're watching: Patient advocates are calling on CMS to cover the new drug and revise its current policy, which limits coverage of the class of drugs lecanemab is part of to patients enrolled in clinical trials or CMS-approved comparative studies.

The Alzheimer’s Association "filed a formal request asking CMS to provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments," said Maria Carrillo, the organization's chief science officer. 

What they're saying: "Peer-reviewed, published results show lecanemab will provide patients in the earliest stages of Alzheimer's more time to participate in daily life and live independently. It could mean many months more of recognizing their spouse, children and grandchildren," Carrillo said in a statement. 

Don't forget: Health experts have said that while lecanemab's approval is a step in the right direction when looking at Alzheimer's treatments, it is not a cure for the disease.

“This is encouraging news, but the approval of lecanemab is just the first step,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation. 

“Alzheimer’s therapies will only be beneficial to patients if the right drug is given to the right patient at the right time based on their unique disease pathology, and for that we need new and novel diagnostic biomarkers,” Fillit added.

Between the lines: A report published Wednesday detailed new information about a trial patient who passed away days after receiving treatment for a stroke and four days after receiving at least their third lecanemab infusion.

The report authors said that the patient experienced brain bleeds that are "unusual" when receiving stroke treatment on its own, but could not pinpoint lecanemab as the primary cause of death.

Catch up fast: Biogen's Aduhelm became the first Alzheimer's to receive FDA approval, in 2021, despite strong objections from the agency's own advisory panel. Scientists said the drug lacked evidence that it even worked.

CMS limited coverage of the drug, which was initially priced at $56,000, effectively making it a commercial failure.

A House investigation found that the FDA did not follow its own protocol when approving Aduhelm and inappropriately engaged with Biogen prior to releasing its decision.

Zoom out: The Aduhelm controversy put the FDA's accelerated approval process used for lecanemab under intense scrutiny. 

The pathway allows patients to access new drugs approved based on results that suggest they are likely to work, instead of real-world clinical results.

The recently enacted government funding bill has a provision to tighten the FDA's oversight of accelerated approvals, giving the agency the power to require post-approval clinical trials to confirm a drug's effectiveness to be underway at the time of approval.

The omnibus also clarifies the FDA's authority to withdraw approvals when a drugmaker fails to conduct such studies.

Editor's note: This story was updated with additional details and context throughout.

FDA grants fast-track approval to experimental Alzheimer's drug

The FDA approved lecanemab, which has shown to slow the progression of Alzheimer's disease.

Picture of a sign displaying the Food and Drug Administration logo outside of the agency's headquarters

Food and Drug Administration (FDA)

Health

Macro

Axios Macro

Change in U.S. nonfarm payrolls

Employers finished the year with a burst of hiring: The economy added 223,000 jobs in December, while the unemployment rate fell back to a half-century low of 3.5%, the Labor Department reported on Friday.  

Why it matters: The labor market is still chugging along with healthy demand for workers, the latest sign that the economy is holding up despite recession fears. 

December's payroll gains are slightly higher than the 200,000 that economists forecast for the month. 

Jobs growth moderated from November's gains, which were revised down to 256,000. In October, updated figures show the economy added 263,000 jobs, 21,000 fewer than initially estimated.

Details: Average hourly earnings, one measure of wage growth, rose by 0.3% in December or 4.6% over the past 12 months — a slightly slower pace than the 0.4% monthly rise in November (which was revised lower from 0.6%). 

The share of people employed or searching for work, known as the labor force participation rate, ticked up only slightly to 62.3%, compared to 62.1% in November. 

The big picture: In an attempt to crush inflation, the Federal Reserve has swiftly raised interest rates and signaled further increases ahead. While job growth has moderated, the labor market has stayed resilient — a welcome development for workers.

The Fed, however, is concerned that hot demand for too-few workers will cause employees to keep raising wages in a way they view as unsustainable, and stoke inflation. 

Where it stands: The December jobs data is one of the last major labor market indicators of 2022, a solid year of job gains that brought the nation back to pre-pandemic levels of employment, and then some. (It is still short of the level where it would have been had the pandemic not happened at all.)

The economy added more than 4.5 million jobs last year, with an average of roughly 375,000 jobs added each month.

But overall labor force participation rate remains stubbornly below its pre-pandemic level. Some of that shortfall is due to deaths from COVID-19, but other reasons include excess retirements and slower immigration. 

Editor's note: This is story has been updated with additional details and a chart.

U.S. adds 223,000 jobs in December, capping a strong year for the labor market

The labor market is still chugging along with healthy demand for workers.

Jobs report

Jobs

Federal Reserve

Top stories & latest news on the Federal Reserve, real-time data, plus the biggest shifts happening in the U.S. and global economy.

Economy

After a record economic expansion, the coronavirus pandemic sent the U.S. economy into a recession as unemployment soared to staggering heights. The country now faces urgent questions about how much stimulus is needed for reeling consumers and businesses, and what a recovery might look like.

Economy & Business

2024 will be an election year like no other, as President Biden seeks re-election amid economic uncertainty, two wars and questions about his age. His likely foe, former President Trump, faces felony charges and vows revenge on his political enemies. Meanwhile, Americans generally are dissatisfied with those choices and are divided over immigration, race, education and more.

Politics & Policy

On the second anniversary of the Jan. 6 insurrection, House Democrats said the speakership fight waged by 20 House GOP rebels is a sign of how little progress has been made toward unity.

Between the lines: "The whole campus is aware of this juxtaposition of these two dates and what they're attempting to do, which is to disrupt our democracy," said Rep. Annie Kuster (D-N.H.).

Axios interviewed multiple Democrats on Thursday who are in the Gallery Group, the roughly 20 House Democrats who formed an impromptu support group after huddling together in the House Gallery on Jan. 6.

"I've been thanking my lucky stars all week that Republicans weren't in charge two years ago," said Rep. Sara Jacobs (D-Calif.).

Rep. Susan Wild (D-Penn.) said GOP Leader Kevin McCarthy cowered "into submission to the extreme fringe" after Jan. 6, "and today, his conference can’t even come together to perform a threshold action."

"It was the government shutdown in ’19, the insurrection of ’21, and now the current chaos of ’23," Rep. Jason Crow (D-Colo.) told Axios. "The common denominator ... is having a handful of Republicans in the House of Representatives who have no interest in governing."

"It's not lost on us that some of these people were the actors that were involved on January 6," Kuster said, referencing House Freedom Caucus Chair Scott Perry (R-Penn.), one of the GOP defectors. "Mr. Perry asked for a pardon because of illegal acts. That's a part of this that is so troublesome."

A spokesperson for Perry did not respond to a request to comment.

Between the lines: The House adjourned Thursday night after 11 failed ballots for McCarthy — but with Republican leadership saying they were optimistic about making progress.

"I'm not putting any timeline on it. We've got some progress going on. Members are talking," McCarthy said Thursday.

The last time a speaker fight went this many ballots was 1859.

Driving the news: President Biden will, for the first time in office, award the Presidential Citizens Medal to 12 people at a ceremony honoring “exemplary contributions to our democracy" on Friday.

Recipients include Capitol Police officers who were injured or died during the riot and election workers who fought off attempts from former President Donald Trump to overturn the 2020 election results.

Incoming House Democratic Leader Hakeem Jeffries will also lead an event in the Capitol at 10 a.m. ET, multiple lawmakers tell Axios.

Shortly after, members of the "Gallery Group" are hosting Capitol Police officers for a lunch to commemorate the work they did on the same day two years ago, members of the group said.

House Democrats connect Jan. 6 to GOP's speakership fight

The anniversary serves as a reminder of how little progress has been made toward unity in the last two years.

Security barricades the door of the House chamber as protesters try to break in on January 6, 2021. Photo: Tom Williams/CQ-Roll Call, Inc via Getty Images

Jan. 6

Axios AI+

The wave of layoffs in tech that continued to mount this week has felt like a shocking and sharp turnabout for an industry that stood on top of the world just a year ago.

Be smart: Tech was never immune from forces in the broader economy, and Silicon Valley has always followed a boom-bust rhythm. But the most recent boom ran so long, many forgot it would have to end someday.

Driving the news: Amazon said Wednesday it will cut a total of 18,000 jobs, including some announced last year as well as new reductions to its retail and HR teams, among others.

Salesforce is laying off 10% of staff, saying it over-hired during the pandemic.

StitchFix on Thursday said it will cut 20% of salaried staff.

Across the industry last year, more than 1,000 tech companies laid off more than 150,000 people, per Layoffs.fyi.

The big picture: Tech's reputation for driving economic growth has always been founded on its ability to deliver productivity gains.

The industry also grew by grabbing market share from a host of consumer and business segments that have moved from analog to digital.

The financial crisis of 2008-9 ushered in an easy-money era in which zero interest rates pushed seas of capital into tech.

The pandemic's arrival brought some sectors to a standstill — but strengthened tech firms, who saw demand spike.

"It’s been a more than decade-long party," said Margaret O'Mara, a University of Washington professor who studies the history of the technology industry. "It’s just extraordinary how long this boom has been."

There was an assumption, O'Mara says, that pandemic-related behavior changes, such as the shift to remote work and buying groceries online, would just continue.

That led many tech companies to go on a hiring spree during the pandemic. The parent companies of both Facebook and Google, for example, grew more than 20 percent last year, while other large tech companies have doubled since before the pandemic.

Then inflation hit, the Fed raised interest rates and the economy softened dramatically — just as many people were returning to pre-pandemic methods of working and shopping. Tech, for all its vast scale and high profit margins, was never going to be immune from that kind of shift.

Online advertising has been hit particularly hard, with Google, Meta, Microsoft and others all noting a pronounced slowdown beginning mid-2022. Many tech companies started by slowing or freezing hiring, but shifted quickly to layoffs once the broader downturn was clear.

The chip sector, whose products had been in short supply, is now having to deal with a glut. 

Micron said in December it would cut 10% of employees, and Intel is said to be weighing cuts that could be even deeper. 

Intel has already made a small number of job reductions and announced plans to cut billions of dollars in costs (which means more layoffs).

What they're saying:  "The next two years are probably going to be the most challenging," Microsoft CEO Satya Nadella said this week.

Yes, but: This isn't the dot-com bust, especially for the biggest companies. While the job cuts are significant, large tech companies are still vital to the economy and they are still making lots of money.

The layoff numbers suggest retrenchment rather than collapse. There are outliers — like Elon Musk's debt-saddled Twitter, which has shed roughly two-thirds of its 7000+ employees — but the most common cutbacks have been in the 10% range.

"They are right-sizing to some degree," O'Mara said. "In a way the pandemic might have delayed a reset that was coming."

What's next: Layoffs are likely to continue as companies that have yet to pare back staff feel compelled to do so — whether to boost profits and please investors, to keep their cost structure competitive with rivals, or to adjust to reduced demand at a time when everyone seems to be cutting back at the same time.

Big Tech's hiring splurge makes cost cuts even harder

Tech companies hit the brakes as slowdown looms

Layoffs are tech's new normal

Tech was never immune from forces in the broader economy, and Silicon Valley has always followed a boom-bust rhythm.

Illustration of a cursor pushing out a worker holding a cardboard box with their possessions.

Layoffs

Column / Signal Boost

Metaverse, VR and AR

From the Valley to D.C., Big Tech players like Facebook, Google and Amazon are under more scrutiny than ever as new technology develops and privacy and antitrust concerns grow in lockstep with companies’ ambitions.

Axios

Friday's top stories

FDA grants fast-track approval to experimental Alzheimer's drug

U.S. adds 223,000 jobs in December, capping a strong year for the labor market

House Democrats connect Jan. 6 to GOP's speakership fight

Layoffs are tech's new normal

A banner year for prescription drugs brings cost concerns

Southwest's meltdown could end up being good for travelers

Next in parade of atmospheric rivers set to slam storm-hit California

Arrest of El Chapo's son sparks deadly riots in Mexico

Immigrants take back American flag in new film

McCarthy talks escalate as speaker vote adjourns on Day 3

2024's Senate surprise