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Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
Published
1 month agoon
By
ironity
U.S. CEO Ivan Cheung said the FDA, which granted accelerated clearance in January, could give full approval as soon as July if the company gets an expedited “priority review” for demonstrating a significant improvement in how early Alzheimer’s is treated.
“We’re literally talking about maybe like five months away, so we are moving with urgency definitely with CMS right now,” Cheung told CNBC in an interview Thursday. The Centers for Medicare & Medicaid Services is the federal agency that will determine how broadly Leqembi, which Eisai has priced at $26,500 a year, is covered for patients diagnosed with early Alzheimer’s.
The company, which developed the drug with Biogen, estimates 100,000 people are expected to receive an early Alzheimer’s diagnosis and become eligible for Leqembi by 2026 though though the number of undiagnosed people is almost certainly higher.
The Alzheimer’s Association estimates that more than 2,000 people aged 65 and older progress from mild to moderate dementia due to the disease per day, making them ineligible for Leqembi.
Early Alzheimer’s typically hits people ages 65 and older, causing cognitive impairment and other issues. Leqembi has shown promise in slowing the disease’s progression in that population, but it carries risks of brain swelling and bleeding.
Medicare published guidance in April 2022 that limits coverage for Alzheimer’s drugs like Leqembi that use antibody treatments to target the plaque that causes the disease. Under Eisai’s current accelerated approval status, Medicare will only cover the costs of people in clinical trials approved by the FDA or National Institutes of Health.
Eisai has completed its phase three trial and is no longer enrolling patients. This means the medication is currently out of reach for most, except the very wealthy. Cheung said the company is not aware of any patients who have managed to get Leqembi covered through Medicare right now.
Even if it gets full approval under the FDA’s “priority review” process, Medicare could still restrict coverage to patients enrolled in research studies approved by CMS, the agency that runs the Medicare and Medicaid federal health insurance programs.
Awaiting FDA answer on timing
The company filed all of its phase three data with its application for full approval in January and should hear back from FDA in March on whether the agency will accept its application. If the agency decides to review Leqembi’s application with priority, it could render a final decision within six months.
Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. But it’s possible that CMS could agree to even broader coverage, possibly with no restrictions, if the agency determines that there’s a high level of evidence supporting the treatment, Cheung said.
“With a high level of evidence … the restrictions should be very limited, or maybe even no restrictions and that is Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria,” he said.
If Medicare continues to restrict coverage, people in rural communities would face a disadvantage because medical institutions and universities are heavily concentrated in bigger cities.
More than 70 members of Congress this month called on Health Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure to ease the coverage restrictions on Leqembi to ensure more access across America.
“Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment,” the lawmakers wrote. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials.”
Drug rollout will take years
If everything goes according to Eisai’s expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer’s patients will be eligible by year three of the drug’s rollout. Eisai said there’s sufficient manufacturing capacity at Biogen’s plant in Switzerland.
But Cheung said the major challenge with rolling out Leqembi is that physicians aren’t geared toward diagnosing early Alzheimer’s because so few treatments exist. CMS also needs to provide broad reimbursement for diagnostic tests, Cheung said. These include PET scans, currently limited to one per lifetime, and cerebrospinal fluid tests which are reimbursed at a low rate, according to the company.
“Every time when you have to adopt a new diagnostic procedure it’s going to just take some time,” Cheung said. “Reimbursement needs to happen for those diagnostic procedures, and radiologists and health-care providers around the country need to start doing that. And there’s a time period it takes for people to get up to speed on how to do that,” he said.
About 15% of eligible patients are younger than age 65 and are mostly covered through private insurance, Cheung said. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said. Eisai will offer copay assistance to people who are covered privately, Cheung said.
“There are more flexibility and multiple approaches to offer very good access with very, very low out of pocket costs for those individuals,” the CEO said. Eisai has a program to provide Leqembi at no cost to uninsured patients who meet eligibility criteria.
Cheung said the $26,500 annual cost of Leqembi should come down over time. Right now, the treatment is administered twice a month, but Eisai is developing a maintenance regimen where patients would receive a single monthly dose after the first 18 months of treatment.
“It’s not approved yet. We expect to file for maintenance dosing by the end of next fiscal year,” Cheung said. Maintenance dosing would reduce the cost of Leqembi by about half, he said.
Medicare under pressure
CMS said in January that it would broaden coverage if Eisai provides data that answers questions about the benefits of Leqembi in slowing cognitive decline and potential harm from side effects such as brain hemorrhages.
“One of the things I would just emphasize is as you know, in this particular class, [we] really wanted to have more information as we learn what these products are going to do,” CMS Administrator Brooks-LaSure said on Tuesday during a call with reporters. “But we continue to be open to hearing new data from manufacturers and advocates.”
Eisai says the data from its phase three trial answers those questions with a high level of evidence, Cheung said.
Medicare’s coverage policy is controversial. The Alzheimer’s Association, in a December letter to CMS, called for full and unrestricted coverage of Leqembi. Robert Egge, the association’s chief policy officer, said it’s the first time CMS has pre-emptively decided to not cover a future class of drugs by default.
The Medicare policy stems from controversy surrounding Aduhelm, another Alzheimer’s antibody treatment developed by Eisai and Biogen. The FDA granted accelerated approval for that treatment in 2021 despite the fact that the agency’s independent advisors said the evidence didn’t demonstrate that it slowed the disease. Three advisors resigned over the FDA’s decision. A congressional inquiry in December found that the approval of Aduhelm was “rife with irregularities.”
Medicare decided last April to restrict coverage on all monoclonal antibodies that target brain plaque for treating Alzheimer’s until it receives more evidence demonstrating a benefit to patients.
“It’s not a reasonable policy because there’s no reason why they had to do this on a class basis,” Egge said.
The American Academy of Neurology, the world’s largest association of neurologists, told Medicare in a letter earlier this month that there is a consensus among its experts that the phase three clinical trial for Leqembi was well designed and the data was clinically and statistically significant.
The clinical trial results, published in the New England Journal of Medicine, found that cognitive decline was 27% slower over 18 months in people who received Leqembi compared with those who did not receive the treatment. But there were also safety concerns with some patients experiencing brain swelling and bleeding.
The death of a clinical trial participant in the Chicago area could also possibly be linked to lecanemab, according to a research letter published in the New England Journal of Medicine in January
AAN’s President Dr. Orly Avitzur called on CMS to revise its coverage limitations so there’s broader access for Leqembi should the treatment receive traditional FDA approval.
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Business
Russia detains Wall Street Journal reporter, plans to hold him until late May
Published
5 hours agoon
March 31, 2023By
ironity
– | Afp | Getty Images
The reporter, Evan Gershkovich, was detained on suspicion of espionage, according to Russia’s Federal Security Service. Shortly after, a Moscow court ordered Gershkovich’s detention to last until May 29, according to the Journal, which cited local reports.
Gershkovich’s detention escalates already high tensions between the United States and Russia. The U.S. government is spending billions to support Ukraine’s defense against invading Russian forces.
Officials from the White House and the State Department spoke with the Journal Wednesday night regarding Gershkovich’s detention, according to a statement from White House press secretary Karine Jean-Pierre. The Biden administration has also been in contact with Gershkovich’s family, and the State Department has been in direct contact with the Russian government, Jean-Pierre said.
Secretary of State Antony Blinken said in a statement his agency has been seeking “consular access” to Gershkovich.
“In the strongest possible terms, we condemn the Kremlin’s continued attempts to intimidate, repress, and punish journalists and civil society voices,” Blinken said.
The FSB alleged Gershkovich “was collecting information constituting a state secret about the activities of one of the enterprises of the military-industrial complex of Russia.” Gershkovich pleaded not guilty to espionage charges, according to Russian state news agency Tass. If convicted, Gershkovich could face up to 20 years in prison.
Daniil Berman, the lawyer of arrested Wall Street Journal reporter Evan Gershkovich, speaks to journalists near the Lefortovsky court, in Moscow, Russia, Thursday, March 30, 2023. Russia’s top security agency says an American reporter for the Wall Street Journal has been arrested on espionage charges.
Alexander Zemlianichenko | AP
The Wall Street Journal adamantly denied the charges, adding that it sought “the immediate release of our trusted and dedicated reporter.”
“We stand in solidarity with Evan and his family,” the Journal said.
Since January 2022, Gershkovich has worked for the Journal in Moscow. Before that, he reported in the country for AFP and The Moscow Times, according to his LinkedIn account. Prior to that he was a news assistant for The New York Times.
Gershkovich’s most recent article, published Tuesday with a co-byline, was headlined “Russia’s Economy Is Starting to Come Undone.”
Russia is one of the worst countries in the world for press freedom, according to a 2022 index from Reporters Without Borders, a nonprofit advocacy group. It has gotten worse since Russia launched its invasion of Ukraine in early 2022, according to the organization.
The country’s government has a long history of harassing journalists, including detaining foreigners on spying charges that appear more politically motivated.
Recently, Russian President Vladimir Putin has overseen a significant crackdown on free speech and political dissent.
Both Blinken and Jean-Pierre stressed the continued importance of heeding the U.S. government’s warning with regards to U.S. citizens residing in or traveling to Russia.
“U.S. citizens residing or traveling in Russia should depart immediately, as the State Department continues to advise,” Jean-Pierre said.
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Business
Virgin Orbit fails to secure funding, will cease operations and lay off nearly entire workforce
Published
6 hours agoon
March 31, 2023By
ironity
Greg Robinson / Virgin Orbit
“Unfortunately, we’ve not been able to secure the funding to provide a clear path for this company,” Hart said, according to audio of the 5 p.m. ET meeting obtained by CNBC.
“We have no choice but to implement immediate, dramatic and extremely painful changes,” Hart said, audibly choking up on the call. He added this would be “probably the hardest all-hands that we’ve ever done in my life.”
The company will eliminate all but 100 positions, amounting to about 90% of the workforce, Hart said, noting the layoffs will affect every team and department. In a securities filing, the company said the layoffs constituted 675 positions, or approximately 85%.
“This company, this team — all of you — mean a hell of a lot to me. And I have not, and will not, stop supporting you, whether you’re here on the journey or if you’re elsewhere,” Hart said.
Virgin Orbit will “provide a severance package for every departing” employee, Hart said, with a cash payment, extension of benefits, and support in finding a new position — with a “direct pipeline” set up with sister company Virgin Galactic for hiring.
Hart has been giving the company’s employees brief daily updates since Monday, when Virgin Orbit delayed a scheduled all-hands meeting at the last minute. Late-stage deal talks had fallen through with a pair of investors over the weekend, but Hart told staff on Monday that “very dynamic” investment discussions were continuing.
Those investor discussions continued this week, with Hart earlier saying leadership would share any updates “as quickly and transparently as we can,” noting that leaking emails “is against company policy,” according to copies of Hart’s emails from Tuesday and Wednesday obtained by CNBC.
The company this week has been steadily bringing back more of its employees from the operational pause and furlough it began on March 15. It initially resumed some work with a “small team” a week later. Amid the broader pause, Virgin Orbit has been working to finish its investigation into the mid-flight failure of its previous launch, as well as finish preparations on its next rocket.
Shareholders unloaded the stock in extended trading Thursday, with shares selling off more than 40% after the announcement. Virgin Orbit stock closed at 34 cents a share at the end of the regular session, having fallen 82% since the beginning of the year.
A Virgin Orbit representative did not immediately respond to CNBC’s request for comment.
Sir Richard Branson poses in front of Virgin Orbit’s rocket manufacturing.
Virgin Orbit
Virgin Orbit developed a system that uses a modified 747 jet to send satellites into space by dropping a rocket from under the aircraft’s wing mid-flight. But the company’s last mission suffered a mid-flight failure, with an issue during the launch causing the rocket to not reach orbit and crash into the ocean.
The company was among a select few U.S. rocket companies to successfully reach orbit with a privately developed launch vehicle. It has launched six missions since 2020, with four successes and two failures.
It has been looking for new funds for several months, with majority owner Sir Richard Branson unwilling to fund the company further.
Virgin Orbit was spun out of Branson’s Virgin Galactic in 2017 and counts the billionaire as its largest stakeholder, with 75% ownership. Mubadala, the Emirati sovereign wealth fund, holds the second-largest stake at 18%.
The company previously hired bankruptcy firms to draw up contingency plans in the event it was unable to find a buyer or investor. Branson has first priority over Virgin Orbit’s assets, as the company raised $60 million in debt from the investment arm of Virgin Group.
On the same day that Hart told employees that Virgin Orbit was pausing operations, its board of directors approved a “golden parachute” severance plan for top executives, in case they are terminated “following a change in control” of the company.

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Business
Nikola announces a $100 million stock offering
Published
7 hours agoon
March 31, 2023By
ironity
Massimo Pinca | Reuters
The company’s shares were down about 5% in after-hours trading following the news.
Nikola’s plan to raise capital comes in two parts. First, the company said, it will offer up to $100 million worth of stock to the public via a traditional secondary offering, with Citigroup underwriting. Citigroup will have the option to purchase an additional $15 million worth of shares.
Secondly, Nikola said it has entered into a forward stock purchase agreement with an unnamed investor. If the public offering raises less than $100 million, that investor has agreed to buy the remainder at the public offering price.
Either way, Nikola will raise $100 million before fees, money that it plans to use for working capital and other general purposes.
Nikola is slowly ramping up production of its electric semitrucks after building just 258 battery-electric trucks in 2022. The company said last month that it expects to build between 250 and 350 of the battery-electric semis in 2023, along with 125 to 150 of its upcoming fuel-cell-powered trucks, set to launch this fall. The fuel-cell trucks will have longer range than the battery-electric versions.
Nikola had $233.4 million in cash and equivalents available as of Dec. 31, down from $315.7 million at the end of September. The company lost $222.1 million in the fourth quarter of 2022.
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