Good afternoon! The launch of the closely watched Alzheimer’s drug Leqembi is off to a slow start.
Still, demand for the treatment from Biogen and its Japanese partner Eisai is rising.
That is the update the 2 drugmakers gave Wall Street during their latest quarterly earnings calls earlier this month.
But before we get into the numbers, here’s why the treatment is such an enormous deal in the primary place: Leqembi became the primary drug found to slow the progression of Alzheimer’s disease to win approval within the U.S. when the Food and Drug Administration cleared it in July.
While the therapy is not a cure, its rollout was a historic moment for the greater than 6 million older Americans who’ve the hard-to-treat condition.
Leqembi can be critical to the long run of Biogen’s business.
The corporate is pinning its hopes on the drug to drive growth because it cuts costs and sees sales plummet for its multiple sclerosis therapies, a few of which face generic competition. Leqembi also marks a promising latest chapter for Biogen’s Alzheimer’s portfolio after the polarizing 2021 approval and launch of an older drug, Aduhelm, which the corporate dropped last month.
Only about 2,000 patients are currently on Leqembi, seven months after it won FDA approval, Biogen CEO Chris Viehbacher told reporters on a media call last week. That makes Biogen’s goal of 10,000 patients treated by the tip of March look increasingly difficult to hit.
But Viehbacher said the corporate had expected more of a “progressive ramp” and is seeing considerable demand for the drug.
Biogen estimates that 3,800 patients have signed up on multiple registries to receive Leqembi as of last month, meaning they’re prescribed or near getting prescribed the drug, in response to Viehbacher. He said that means 260 to 265 patients were being added to registries each week as of January, a couple of 56% increase from December.
Morgan Stanley analysts called that registry data “encouraging” in a note last week, but said the firm is waiting to see those patients begin the therapy.
Viehbacher argues that demand is not the issue. The true hurdle is having systems that may “accommodate this latest flow of patients.”
Viehbacher is referring to the complex process patients must undergo before they receive Leqembi. To get the drug, a patient often must secure an appointment with a neurologist, which may already be a difficult task by itself.
The neurologist then must run special tests to substantiate that the patient is at an early stage of Alzheimer’s and has a sticky toxic protein called beta-amyloid, which is a trademark of the disease. If eligible, the patient can be prescribed Leqembi, which is run as a one-hour infusion every two weeks.
Viehbacher also highlighted challenges related to MRI monitoring during a separate earnings call with investors. Leqembi’s prescribing label says patients should get multiple MRIs in the course of the first 12 months of treatment to ascertain for signs of ARIA, a side effect that causes brain swelling or bleeding and might be fatal in rare cases.
But “once we initiate the infusion, you could have to have the primary MRI inside the first two weeks,” Viehbacher said in the course of the call. So, some patients don’t need to begin the drug until they’ve that first MRI appointment scheduled, he said.
“Until people get the hang of this, getting all that coordination, I feel that appears to be where … certainly one of the bottlenecks is,” Viehbacher said.
Leqembi brought in $7 million in fourth-quarter revenue and $10 million in full-year sales, in response to Eisai. Wall Street analysts are on the lookout for much more this 12 months.
“Growth is good – but we want to see big acceleration,” Jefferies analysts wrote in a note last week.
Notably, Biogen and Eisai are also working toward FDA approval of an injectable version of Leqembi, which showed promising initial ends in a clinical trial in October.
The injectable form could be a latest and more convenient option for administering the antibody treatment to patients, which could pave the way in which for higher uptake.
And increased use cannot come soon enough for the drugmakers: Eli Lilly’s own Alzheimer’s drug, donanemab, could win FDA approval any day this quarter.
The most recent in health-care technology
Headsets are making some users nauseous. Here’s what experts say will help
Apple’s Vision Pro headset is displayed on the Apple Fifth Avenue store in Manhattan in Recent York City, U.S., February 2, 2024. REUTERS/Brendan McDermid
Brendan Mcdermid | Reuters
It has been just a few weeks since Apple launched its latest mixed reality headset, the Vision Pro, after months of anticipation. CEO Tim Cook told CNBC’s Jim Cramer that the headset is “tomorrow’s technology today,” and CNBC’s Todd Haselton called it the “most fun” latest product he’s tried in years.
But headsets are usually not for everybody. Some initial users have said they experienced discomfort like headaches and motion sickness.
As an illustration, in a post on the social media site X, one user said Apple’s Vision Pro caused severe motion sickness, “identical to all other VR.” One other person experienced nausea lower than half-hour into wearing the device, they usually urged others to “proceed with caution” in the event that they get carsick often. Even so, this person called the Vision Pro a “really incredible experience,” in response to an X post.
Apple released a list of suggestions to assist users in the event that they experience motion sickness while using the Vision Pro, like taking a break, reducing the scale of their window and avoiding experiences that feature numerous movement. The corporate said users should talk with their doctor if their symptoms are severe and protracted, in response to the location.
Feelings of nausea and headaches are usually not unique to Apple’s device, and users have encountered these issues with headsets from corporations like Meta for years. CNBC spoke with some experts to know why some people have trouble wearing VR, AR and mixed reality headsets.
Dr. Joanna Jen, a neurologist at Mount Sinai Health System, said much about motion sickness remains to be unknown, though there are some leading theories about why it happens. She said one popular theory is that motion sickness occurs when there may be an incompatibility, or mismatch, between the sensory inputs the brain and body are receiving.
As an illustration, should you are flying in a headset but standing relatively still, that might be a sensory mismatch.
Jen said everyone has a special sensitivity, and a few people may adapt and construct up a tolerance for the headsets with time. She said should you feel like it’s essential to take a break, then achieve this, and you’ll be able to all the time try again later.
“Moderation is essential,” Jen said in an interview. “Don’t overdo it.”
Dr. Natascha Tuznik, an infectious disease specialist and associate professor on the University of California, Davis, helps run the college’s travel clinic, where motion sickness comes up often. With headsets specifically, she said users can attempt to alleviate symptoms by reducing the length of their sessions, ensuring that the device is fitted and arrange properly, moving by transporting or warping inside the headset as a substitute of walking where applicable and on the lookout for games which have a static reference point.
Tuznik said there’s not an important technique to predict whether you may experience motion sickness, so testing out a headset at a friend’s house or a store could possibly be worthwhile.
“Should you know the way you react to non VR situations by which you’ll be able to turn out to be motion sick, for instance, the way you react in a automobile or on a ride or on a ship, then it’s extremely likely that you’ll experience an identical degree of effects while you’re using VR,” Tuznik told CNBC.
In essence, take heed to your body! Be aware of how you’re feeling when wearing an immersive headset, and do not force it if it doesn’t seem right. Unfortunately, some tech just doesn’t work for everybody. The silver lining, nonetheless, is that nausea could prevent $3,500 on the Apple Store.
Be happy to send any suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com and Ashley at ashley.capoot@nbcuni.com.