Yahoo Finance Alzheimer's drug Leqembi: The twice-monthly infusion could be available in injection form
Makers of the new Alzheimer's drug, Leqembi, say their twice-monthly infusion could be available in injection form at pharmacies by early 2025 — if all goes well in ongoing trials and the regulatory process.
Eisai and Biogen (BIIB), co-developers of the recently approved intravenous (IV) drug, announced new data Thursday that shows an injection under the skin could deliver about the same results as an infusion through IV. That could allow patients to switch to using the injection alone, if the data supports it long-term, or alternate between the two if the patient is comfortable with at-home injections.
The new data shows an increase in clearing beta-amyloid plaques in the brain — a controversial telltale sign of Alzheimer's that served as the basis of Leqembi's clinical trials — by 14% through injection compared to IV.
The injection option, analysts say, could increase the revenue potential for the drug. "Overall, we view this update as highly positive, and expect these results to raise expectations for Leqembi’s potential market penetration, as a (subcutaneous) formulation could ease the burden on patients and the healthcare system and accelerate uptake," Goldman Sachs analysts said Thursday.
While some investors continue to anticipate a slow initial launch, Eisai executive vice president Alex Scott told Yahoo Finance that uptake for the IV is actually going better than expected.
"The formulary approvals are happening at a faster clip than we had in our plans," he said.
Removing barriers
In fact, the demand for the drug is creating new treatment models in places like Dallas, where one health system is putting a neurologist, infusion centers, and MRI monitoring all under one roof — three key elements needed to monitor patients in a timely manner rather than scheduling and coordinating separate visits for each step.
Meanwhile, companies are already vying for their piece of the business.
LabCorp (LH), for example, announced a blood-based test to help identify biomarkers that are signals of Alzheimer's, thereby identifying more potential patients for the drug. Another example is GE Healthcare (GEHC), which partnered with Eisai early on in the R&D process. It is lobbying for its PET, or imaging scans that can be used for the brain, to be used more than once during a patient's therapy journey.
Building new infusion sites is another way to get a share of the business — but it is a limiting factor in the eyes of investors.
"We are encouraged by these results and are positive on the commercial opportunity ... which would circumvent the need to build up infrastructure around infusion centers and greatly increase ease of administration," Leerink Partners analysts said in a note Thursday.
The prospect of a self-administered version, similar to the injectables used for insulin, migraines, and popular weight loss drugs today, opens up access for patients.
"We want something that is interchangeable, because that just gives more choice," Eisai's Scott said. "Patients are still working. Patients might still be driving. They might be playing golf. For them to be tethered to an infusion chair every two weeks, is not something they may want in their life," he added.
But, he added: "We, as a company, are not going to try and steer utilization. We see this as physician choice, patient choice."
Pricing, IRA on the horizon
Leqembi's fate is far different from its predecessor Aduhelm, also co-developed by Eisai/Biogen, which saw slow uptake despite getting FDA clearance. Concerning side effects, such as brain swelling, and an initially high sticker price, $56,000 per year before it was reduced to $28,000, contributed to the concerns.
Leqembi, while also facing some concerns over brain swelling, has started off at $26,500 per year. Eisai and Biogen published a lengthy justification for the price.
This has put Aduhelm, which was eventually taken off the market, clearly in the rearview mirror for the two companies. But it doesn't put pricing pressures away for good — Medicare drug pricing negotiations, part of the Inflation Reduction Act (IRA) are looming on the horizon.
The company has still not decided how it will price the injection version differently from the IV version.
"This sets us up for [the] IRA," Scott said, in anticipation of wider uptake and longer-term use.
"We're going to have to bring a sophisticated approach — we'll have to see how these first rounds of negotiations go — but I'm very comfortable and confident that Leqembi will be one of those products in the future. We'll address that," he said.
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.
