PINK SHEET: Lilly Pre-Approval Spadework Includes Alzheimer’s Blood Test Development, Unbranded DTC Ads

08 Mar 2024 ANALYSIS by Cathy Kelly;
Executive Summary

Donanemab’s review delay will create more distance from Lilly’s direct-to-consumer advertising spotlighting its commitment to Alzheimer’s research. The company has also been supporting development of blood-based tools for early diagnoses, though they would not eliminate PET scans.

Eli Lilly and Company launched unbranded direct-to-consumer TV advertising following the Super Bowl in February that highlights the company’s long history in the field of Alzheimer’s research.

In addition to donanemab, the company has marketed radiopharmaceuticals for amyloid PET scans used for research into treatments for years.

The timing of the spot would have neatly corresponded to the US Food and Drug Administration’s previously anticipated approval of the company’s anti-amyloid drug for Alzheimer’s disease, donanemab, before the end of March.

But that expectation has been disrupted by the FDA’s 8 March announcement that it would call an advisory committee meeting to consider questions relating to the safety of donanemab, the design of its Phase III clinical trial, and what happens to patients after treatment is stopped. (See box for more coverage of the delay.)

The ad, themed “Don’t Forget,” follows an older woman, apparently suffering from Alzheimer’s, whose home is papered with handwritten notes that are reminders (“remember to turn off oven”) and encouragement (“you are still you”).

Scenes of her daily activities are interspersed with images from earlier points in her life, including as a child on a beach. It closes with the statements, “People with Alzheimer’s take notes to remember. Thirty years of research hasn’t forgotten them,” and the Lilly logo. It does not mention donanemab by name.

The ad is part of a broader corporate campaign that also includes unbranded segments on obesity treatment. The ads are airing nationally, on television and digital/social channels, and will continue into the coming months.

 Lilly Piloting Distribution Of Blood-Based Test For Early Diagnosis

Separately, Lilly will also continue its support for blood-based screening diagnostics for detecting Alzheimer’s pathology, the company said. Lilly is piloting the distribution of such a test and plans to expand availability of the assay during 2024.

At the same time, Lilly is partnering with other organizations with much larger footprints in the diagnostic space on their development of blood-based diagnostics, including via formal partnerships with Roche Molecular Diagnostics on a P-tau181 assay and Quanterix focused on a P-tau217 assay.

The Lilly test is being developed by the company’s subsidiary, Eli Lilly Clinical Diagnostics Laboratory. It will not be offered as a companion diagnostic for donanemab, assuming the drug is approved. Instead, the company hopes it will advance the diagnostic ecosystem for the disease.

“We believe blood diagnostics could offer a practical, broadly accessible tool for physicians to use to confirm or rule-out the pathology of Alzheimer’s disease,” Lilly said. “It is critical to continue to invest in areas that equip healthcare providers and patients with multiple tools that allow for timely and accurate diagnosis of Alzheimer’s disease to inform appropriate treatment.”

Blood-based diagnostics offer less invasive and much less expensive ways to identify patients who might benefit from treatment with an anti-amyloid therapy than a PET scan or a cerebrospinal fluid test.

But at this point, Lilly does not anticipate that blood tests available for Alzheimer’s disease diagnosis will completely replace the need for amyloid PET tracers or CSF testing, according to a company spokesperson.

P-tau217 Test, In Particular, Shows Good Correlation To PET Scans

The Lilly assay also measures P-tau217, “which has shown the ability in a research setting to distinguish Alzheimer’s disease from other neurodegenerative disorders and has better performance relative to other analytes,” the company explained.

“Clinical validation of our P-tau217 test was performed in a screening cohort from a large, multicenter trial population and consisted of 2,071 participants aged 60 and over who presented with cognitive decline and did not have significant co-morbidities,” the firm continued.

In the trial population, “the validation demonstrated that this test has a sensitivity of 91%, specificity of 90%, [positive predictive value] of 95% and [negative predictive value] of 84%, with an indeterminate rate of 18%, as compared to amyloid-PET scan results.”

A “strong correlation” between the ability of blood-based tests, particularly p-tau217, and PET scans or CSF testing for the presence of amyloid plaque was also reported in a study published recently in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.

Conducted by the Global Alzheimer’s Platform Foundation in partnership with a network of clinical research sites, the study known as Bio-Hermes was also supported by a number of pharmaceutical companies, including Lilly, Biogen, Inc., AbbVie Inc. and Merck & Co., Inc.. (Also see “Medicare Alzheimer’s Coverage Policy Advancing Clinical Trial Diversity Efforts” – Pink Sheet, 21 Nov, 2022.)

“We expect the Bio-Hermes data will make a substantial contribution to how the field characterizes and diagnoses the pathologies underpinning Alzheimer’s and related dementias,” said GAP President John Dwyer. “We designed this study to simplify and accelerate this complicated and time-consuming diagnostic process.”

Reimbursement Work Continues

Lilly’s DTC campaign might be the most visible aspect of the firm’s pre-approval work, but the most vital is arguably the effort to get Medicare to loosen its coverage restrictions on amyloid-targeting products, which currently would require donanemab patients to enroll in a registry even if the product receives full approval from FDA.

Most recently, company researchers published a paper arguing that the TRAILBLAZER-ALZ 2 data indicates CMS should allow access to the drug without restrictions. (Also see “Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says” – Pink Sheet, 23 Feb, 2024.)

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