Eli Lilly is calling on European countries to make “urgent improvements” to their Alzheimer’s disease diagnostic testing practices just weeks after nabbing a new approval on the continent for its Alzheimer's therapy Kisunla.
The Indianapolis Big Pharma has teamed up with leading Alzheimer's experts at this year's Alzheimer Europe Conference to call for “urgent improvements to diagnostic pathways to ensure people in Europe can benefit from new therapeutic innovation.”
Lilly points to a recent survey, published in the Journal of Alzheimer’s Disease, that found 70% of clinicians believe biomarker tests, which can find evidence of Alzheimer's or dementia, are “important or extremely important." Still, such tests remain "underutilized," according to Lilly's Oct. 7 release.
The survey questioned clinicians who treat patients with mild cognitive impairment (MCI) and Alzheimer's in France, Germany, Italy, Spain, the U.K., Japan and the U.S.
The team found that across these countries, fewer than 1 in 5 patients (15.2%) received biomarker testing to confirm the specific pathology, with those in Germany and the U.K. the least likely to receive these tests, according to the journal.
As a result, experts warn Alzheimer's and dementia “remain critically underdiagnosed,” Lilly said in the release, which has the effect of "denying patients the opportunity to access treatment and care options."
Lilly markets Kisunla, which works as an amyloid-plaque-targeting therapy and has an FDA approval for early symptomatic Alzheimer's, which includes the MCI or the mild dementia stages of the disease.
The drug was approved by the FDA last year and received a final European sign-off just last month.
To qualify for the drugs, patients must have a confirmed amyloid pathology, which can be done via several routes including a PET scan, a blood test or an MRI.
Lilly also markets Amyvid, which works as an injectable prescription imaging agent to find high level of plaques. These are a buildup of a protein called amyloid beta in the brain that, if found, can be ultimately used by patients or their doctors to help prescribe Alzheimer's meds such as Kisunla.
More diagnoses of Alzheimer's also mean potentially more uptake for medicines. Rival drug Leqembi, marketed by Biogen and Eisai, was also approved in the EU earlier this year.
“Emerging therapies that target the pathology of Alzheimer's disease offer hope to slow progression and delay the need for care services,” said Stéphane Epelbaum, M.D., Ph.D., associate vice president for international medical affairs at Eli Lilly, in a statement.
“But this possibility hinges on early detection, as approximately one-third of individuals in early symptomatic stages of the disease will progress to more advanced clinical stages within one year. Timely and accurate diagnosis is essential to ensure patients can access the next generation of Alzheimer's disease care.”