One of the key therapeutic targets in Alzheimer's disease is amyloid, a sticky protein that builds up in clumps outside neurons, causing cell death and cognitive decline. However, new therapeutics targeting the protein have only shown mild efficacy in delaying disease progression. As a result, drug developers are looking for other biological targets.
An advisory committee for the US Food and Drug Administration (FDA) voted 6-0 in favor of full approval for Leqembi, Eisai and Biogen’s treatment for Alzheimer's disease. The decision was made based on results from the Clarity AD study, which the committee members believed strongly supported its clinical benefits for patients.
In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer's drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9th, shows that the agency considers the drug’s efficacy well-supported by evidence from a recent study and that the risk of adverse events does not rule out full approval.
Agitation is a common symptom of Alzheimer’s disease, negatively impacting the quality of life for patients and their caregivers. An advisory committee for the US Food and Drug Administration (FDA) has given the nod to expand the indication of Takeda and Lundbeck’s Rexulti, a widely used atypical antipsychotic, to include the treatment Alzheimer’s disease-related agitation (AAD).
Eisai’s CEO Ivan Cheung told Fierce Pharma he is not too worried about the long-term success of Leqembi in light of the US Centers for Medicare and Medicaid Services (CMS) declined to change its rule about reimbursement for drugs in its class. The rule states that drugs targeting amyloid, a key protein in Alzheimer’s disease, can only be covered for patients in clinical trials.
The US Veteran’s Administration has decided that it will cover Leqembi, Eisai and Biogen’s new therapeutic for Alzheimer’s disease. The announcement comes just weeks after the Centers for Medicare and Medicaid Services (CMS) decided not to expand coverage of the drug to patients outside of clinical trials, a restriction put in place after last year’s approval and failed market release of Aduhelm.
The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another amyloid-targeted Alzheimer’s disease therapy, followed by its controversial accelerated approval.
Following the controversial approval of the Alzheimer’s drug Aduhelm, the US Centers for Medicare and Medicaid Services (CMS) agreed to only pay for drugs in its class, amyloid-targeted therapies, when used in patients enrolled in clinical trials. A group of Senators have penned a letter to Xavier Becerra, Secretary of the Department of Health and Human Services (DHS) and the CMS Administrator Chiquita Brooks-Lasure.
Care for people living with Alzheimer’s and related dementias (ADRD) is emotionally taxing for caregivers and costly for Medicaid, which spent $146 billion on ADRD care in 2022 alone. In a newly published article in Health Affairs, authors give 5 recommendations to help revamp ADRD care payment models to reduce the burden on Medicaid and caregivers.
With the successful accelerated US approval of lecanemab, Eisei and Biogen’s new Alzheimer’s drug, some worry the drug’s high price will limit access to many patients. The Institute for Clinical and Economic Review (ICER) estimated the drug’s value somewhere between $8,500 and $28,000 per biweekly treatment, well below the manufacturers’ estimated price of $26,000. Some worry it will go the way of the ill-fated Aduhelm.
Alzheimer’s is the most common cause of dementia, affecting 6.5 million people in the US alone. Unfortunately, a crisis is brewing in many countries aging populations; the number of people facing the disease will double in the next 40 years. A newly published article in AJMC breaks down the societal and economic impact of the disease and explains the role of managed care in the relieving this burden.
Late last year, reports surfaced that Cassava Sciences had falsified trial data regarding its experimental drug for Alzheimer’s disease. Now, the US Department of Justice (DOJ) has launched a probe into the allegations, sending the company’s share prices down by 30%. The claims originated from two doctors, represented by the law firm Labaton Sucharow, who found irregularities in data coming from Hoau-yan Wang, an Associate Medical Professor at City University of New York, and Lindsay Burns, Cassava’s VP of neurosciences.
Biogen has written off its remaining Aduhelm inventory in a filing to the Securities and Exchange Commission (SEC) filing. The company declared that its stock of the failed Alzheimer’s drug was functionally worthless, in contrast with a $233 million valuation towards the end of 2021. The remaining stock will be available to patients that are already using the drug, such as those in clinical trials.
The secretive startup TrueBinding announced that it raised $100 million in investments for its experimental antibody drug for Alzheimer’s Disease and stroke. The press release was muted, just over 30 words. TrueBinding has not revealed who the investor is, the third to fund the company since 2019.