CNN
—
The U.S. Food and Drug Administration could decide this week whether to grant expedited approval to lecanemab, an experimental dementia drug, according to Eisai and Biogen, the companies that make the drug.
Lecanemap – one of the first experimental dementia drugs to appear to slow the progression of cognitive decline – has shown ‘potential’ as a treatment for Alzheimer’s disease, according to Phase 3 trial resultsbut has raised safety concerns due to its association with certain serious adverse events, including swelling and bleeding in the brain.
In July, the FDA accepted Eisai’s biologics license application for lecanemab under the fast-track approval and granted priority drug review, according to the company. The Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and “fill an unmet medical need” while the drugs continue to be studied in larger, longer trials.
The FDA is expected to decide whether or not to grant expedited approval to lecanemab by Jan. 6, Eisai spokeswoman Libby Holman confirmed to CNN.
“If lecanemab is approved by the FDA under the fast track, Eisai will do its best to make lecanemab available as soon as possible,” Holman wrote in an email. “Eisai aims to file an additional biologics license application soon for mainstream approval in the United States and to file marketing authorization applications in Japan and Europe by the end of the year. Eisai’s 2022 fiscal year, which ends March 31, 2023.”
The Alzheimer’s Association also expects the FDA to take action by Jan. 6, Maria Carrillo, the group’s chief scientific officer, said in a statement.
“We believe, based on all of the positive clinical trial data for this treatment, that the FDA should approve it. Published, peer-reviewed results show that lecanemab will give patients in the early stages of Alzheimer’s disease more time to participate in daily life and live independently. It could mean several more months to recognize their spouse, children and grandchildren,” Carrillo said in the statement.
She added that the Alzheimer’s Association hopes the Centers for Medicare and Medicaid Services will “move quickly” to cover the drug and “review its coverage decision that currently blocks access to this treatment.” CMS determines whether to cover FDA-approved therapies based on their safety and effectiveness.
“The Alzheimer’s Association has filed a formal request asking CMS to provide full, unrestricted coverage for FDA-approved treatments for Alzheimer’s disease,” Carrillo said.
Lecanemab, a monoclonal antibody, is not a cure, but works by binding to beta-amyloid, a hallmark of Alzheimer’s disease.
At the end of November, the results of an 18-month phase 3 clinical trial published in The New England Journal of Medicine showed that lecanemab “reduced amyloid markers in early Alzheimer’s disease and caused a moderately less decline in measures of cognition and function than placebo at 18 months, but was associated with adverse events “.
The results also showed that approximately 6.9% of trial participants who received lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared to 2.9% of those who received a placebo. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group.
The most common adverse events in the lecanemab group were reactions to intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening. .
Some people with ARIA may have no symptoms, but sometimes it can lead to hospitalization or lasting impairment. And the frequency of ARIA seemed to be higher in people who had a gene called APOE4, which it can increase the risk Alzheimer’s disease and other dementias. ARIA “were numerically less common” among non-APOE4 carriers.
The trial results also showed that approximately 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group. .
Even though the FDA is proposing expedited approval for the drug, it will still be studied in more robust trials. And if those trials confirm that the drug provides clinical benefit, the FDA could grant traditional approval. But if the clinical trial doesn’t show benefit, the FDA has regulatory procedures that could lead to the drug being pulled from the market.
“If and when this drug is approved by the FDA, it will take some time for clinicians to be able to analyze how this drug may or may not be effective in their own patients,” especially since carriers of the APOE4 gene may be at greater risk for side effects, Dr. Richard Isaacson, director of the Alzheimer’s Disease Prevention Clinic at the Center for Brain Health at Schmidt College of Medicine at Florida Atlantic Universitywho does not participate in the study of lecanemap nor in its development, said in november.
More than 300 treatments for Alzheimer’s disease are in clinical trials, according to the Alzheimer’s Association. Alzheimer’s disease was first documented in 1906, when Dr. Alois Alzheimer discovered changes in the brain tissue of a woman who had memory loss, language problems and unpredictable behaviors.
The wasting disease affects more than 6 million adults in the United States.
0 Comments