Results from a study evaluating gantenerumab in people with mild cognitive impairment due to Alzheimer’s disease found the drug was well tolerated but did not meet their goal in demonstrating clinical decline.
“So many of our families have been directly affected by Alzheimer’s, so this news is very disappointing to deliver,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are profoundly grateful to the study participants, their care partners and study sites for their contributions to this research. While the GRADUATE results are not what we hoped, we are proud to have delivered a high quality, clear and comprehensive Alzheimer’s dataset to the field, and we look forward to sharing our learnings with the community as we continue to search for new treatments for this complex disease.”
According to a news release, Roche remains committed to Alzheimer’s disease, one of the most complex neurological disorders and a major public health challenge. The company is continuing to develop and deliver tests to enable early and accurate Alzheimer’s diagnosis and has a pipeline of investigational medicines for different targets, types and stages of the disease.
Voices of Alzheimers, an advocacy organization guided and led by people affected by cognitive diseases, also expressed disappointment over the apparent failure of the new drug.
Voices of Alzheimer’s said in a news release that it is adamant that even though Roche was unable to prove a statistically significant impact of its drug gantenerumab, earlier results from Eisai and Biogen and still unknown results from Eli Lilly’s donanemab should still lead to a reconsideration by Medicaid of its decision last year to deny coverage for monoclonal antibody treatments for Alzheimer’s.
The drugs offer hope to millions of people worldwide who are currently living with Alzheimer’s without a therapy available that can alter the course of the disease, according to the organization.
The new results, said Jim Taylor, President of Voices of Alzheimer’s and long-time care-partner, should not be used by Medicaid to justify its blanket decision last year to refuse to cover the class of new drugs.
“While Roche seemingly did not meet its goals,” Taylor said, “other compounds are generating evidence that the federal government should change its discriminatory policies on coverage of Alzheimer’s treatments. We need to keep the pipeline of new treatments flowing from research to patients, not cut it off at Medicare.”
The results released by Roche for gantenerumab showed relative reduction in clinical decline of 8 percent in one trial and 6 percent in an identical trial compared to placebo.
In contrast, Eisai and Biogen released preliminary data in late September about their new drug called lecanamab indicating delayed progression of cognitive loss by 27 percent compared to placebo.
“We are disappointed,” said Terrie Montgomery, a founding board member of Voices of Alzheimer’s who is living with early-onset Alzheimer’s. “But we will not allow our momentary disappointment to diminish our efforts to demand that treatments are fully covered by Medicare and Medicaid once they are determined safe and effective by the FDA.”
The FDA may consider several new treatments for Alzheimer’s in 2023, potentially starting in January, at which point the Centers for Medicare and Medicaid would face intense pressure from patients to justify its blanket restriction on coverage, according to Voices for Alzheimer’s.
“It is our strong belief that Medicare has discriminated against people with Alzheimer’s and their families for the last decade by failing to provide coverage for Alzheimer’s diagnostics and FDA-approved treatments,” said Phil Gutis, a founding VOA board member and person living with early-onset Alzheimer’s. “We are deserving of the same access to innovation as any other disease area.”
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Crystal Graham
