To expand the population for the anti-amyloid Alzheimer’s drugs, Lilly and Biogen are testing presymptomatic patients. Will doctors be open to this paradigm-shifting change?
Both Eli Lilly and Biogen are driving toward clinical results that could show their Alzheimer’s disease medicines are effective in slowing disease progression in patients who are not yet showing symptoms. That could be practice changing news—but given the challenge Biogen has had getting symptomatic patients with Alzheimer’s to take the anti-amyloid drug Leqembi, analysts are wondering how they will convince doctors to start looking for signs of the disease even earlier.
Biogen and partner Eisai received approval for Leqembi, a disease-modifying anti-amyloid beta therapy, in 2023. Lilly’s Kisunla hit the market just months later. But uptake for both therapies has been slow as physicians struggle to adapt to the new treatment paradigm.
Leqembi collected $121 million in sales for the third quarter, according to Biogen’s earnings report, released Thursday. This represented 82% growth, with U.S. sales of $69 million.
To expand the population for the anti-amyloid drugs, Lilly is awaiting results from the TRAILBLAZER-ALZ-3 study of presymptomatic patients taking Kisunla. Biogen, meanwhile, is running the AHEAD 3-45 study of a similar population with Leqembi.
Executives on Biogen’s third-quarter earnings call said they would apply lessons learned and relationships built from the symptomatic rollout of Leqembi to the new population. CEO Chris Viehbacher pointed to the introduction of a subcutaneous version of the drug called Leqembi IQLIK, which launched this month for the existing symptomatic indication. This formulation can ease the treatment burden, the company has argued, making patients more comfortable starting therapy earlier, rather than going in for infusions.
“A lot of what we’ve been doing is trying to make the care pathway simpler for physicians with the idea of being able to increase throughput,” Viehbacher said.
Until recently, patients had to undergo advanced imaging and invasive diagnostic procedures to start on therapy. But that is changing as companies like Roche and Lilly roll out their newly approved blood-based biomarker test that should ease diagnosis.
Uptake of the new biomarker tests has been swift, according to Alicia Alaimo, president and head of North America commercial operations for Biogen. Lilly and Roche’s new Elecsys pTau181 test can help rule out Alzheimer’s and flag patients for additional follow up. It’s designed to be used in the primary care setting and facilitate referrals to neurologists.
With the new subcutaneous Leqembi, plus easier testing, Viehbacher said, “you’re dramatically reducing the workload at the neurology [clinic].”
Biogen is also seeing an uptick in eligible patients. Right now, about half of the patients who get into see a neurologist are not actually eligible for treatment, Alaimo said. If triaging can be improved, so can treatment uptake for Leqembi.
The company is also not alone in promoting treatment for Alzheimer’s now that Leqembi and Kisunla are available, Alaimo noted. This is helping to drive physician awareness of the new therapies and tests.
Alaimo also said that commercial payers will be key as the conversation shifts toward presymptomatic patients who may be too young to be covered by Medicare.
“Clearly some of those conversations have already happened, because we do have some younger population patients that want to go on product,” Alaimo said. “By the time these trials read out, I do think the capacity will be also much better.”
