New marketing campaigns about forgetfulness and distraction could lead people to seek the costly Aduhelm drug for Alzheimer’s disease even if they haven’t been diagnosed with the condition, several experts have warned.
By working to expand the market of people seeking treatment for mild cognitive impairment, Biogen could needlessly expose many people to a drug with known risk but as yet unproven potential benefit, some researchers said. (See “Do we all have Alzheimer’s? Drug makers might want you to think so,” Adriane Fugh-Berman and Patricia Bencivenga of Georgetown University, Baltimore Sun, July 16, and “‘When Memory Fades’: Misinformation about Alzheimer’s disease and Aduhelm must be limited,” Madhav Thambisetty of Johns Hopkins University, STAT, July 21.) Continue reading
Editor’s Note: This is part 2 of a two-part package on the pipeline for Alzheimer’s disease drugs. Check out part 1.
While the controversy surrounding the FDA’s approval of Biogen’s adumanucab for Alzheimer’s disease continues, several other drug companies are developing their own therapies to prevent or slow the progression of the disease.
One of those new drugs, ALZ-801, began National Institute of Aging-funded Phase 3 trials on June 4. Unlike aducanumab or other drug candidates from Eisai, Eli Lilly and Roche, which attack amyloid plaque after it forms in the brain, biotech startup Alzheon, Inc. aims to help people with AD who have two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4), a known risk factor for Alzheimer’s disease. The goal is to prevent plaque from forming in the first place or prevent additional plaque from forming in those who already show clinical symptoms of Alzheimer’s. ALZ-801 is also the only drug currently under investigation administered orally and which uses precision medicine strategy (factoring in individual genetics and lifestyle), according to the company. Continue reading
Eli Lilly recently announced that the FDA had granted a breakthrough therapy designation for donanemab, its investigational antibody therapy for Alzheimer’s disease. The designation means the FDA will expedite the drug’s development and review because it treats a serious condition, and early evidence has shown enough improvement on key clinical measures compared to other drugs on the market. This should mean it has a good chance of being effective in treating the condition.
Donanemab, also called N3pG, is an investigational antibody that targets a modified form of beta-amyloid, aiming to clear out plaques that have built up in the brain. Lilly’s Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic Alzheimer’s. The results, which appeared in the May 6 New England Journal of Medicine, concluded that “donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed.” Continue reading
Photo: Global Panorama via FlickrGroup of Alzeimer’s patients on a walk with caregivers
Liz Seegert, AHCJ’s topic leader on aging, contributed to this article.
Federal policy experts and the influential Institute for Clinical Effectiveness (ICER) have announced separate discussions this month of the Biogen drug aducanumab (Aduhelm) to treat Alzheimer’s disease.
On July 15, ICER will ask one of its expert panels, the California Technology Assessment Forum, to consider the evidence available for aducanumab’s benefits and risks and vote on a series of questions about its effectiveness and value. ICER’s reports have clout because insurers use them to help determine how to cover drugs and medical treatments. The independent group earlier released a report critical of the evidence presented to date about aducanumab. Biogen, which told AHCJ it disagrees with ICER’s opinion of its drug, plans to have a representative speak at the meeting. Continue reading
Part two of two parts; the first ran Thursday, June 10.
There’s still a great deal we don’t yet understand about aducanumab (brand name Aduhelm) or its longer-term effects. If early-stage Alzheimer’s disease is diagnosed in time for someone to begin taking the drug, are the potential adverse effects cumulative? Could long-term toxicity build up over time? How long might the drug stave off development of the plaque, and how long might it slow down the process of cognitive decline, if at all, and how will clinicians assess its benefit in patients? Continue reading