Looking Past Amyloid – The Future of Alzheimer’s Therapeutics
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.
FDA Advisory Committee Votes in Favor of Eisai, Biogen’s Leqembi
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.
FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi
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.
FDA Advisory Committee Recommends Rexulti for Alzheimer’s-Related Agitation
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 CEO Not too Worried About Leqembi After CMS Keeps Anti-Amyloid Rule
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.
US Veteran’s Administration to Cover Alzheimer’s Drug Leqembi
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.
FDA to Hold Adcomm on Eisai’s Leqembi Alzheimer’s Treatment by July 6th
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.
US Senators Call for Expansion of Medicare Coverage for Amyloid Alzheimer’s Treatments
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.
5 Recommendations to Revamp Dementia Care Payment Models
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.
High Price of New Alzheimer’s Drug May Reduce Patient Access
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.
The Impact of Alzheimer’s Care: A Managed Care Perspective
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.
US Department of Justice Opens Investigation into Cassava Alzheimer’s Drug Data Manipulation Controversy
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 Writes Off Aduhelm Stock
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.
Small Startup TrueBinding Raises $100 Million for Stroke and Alzheimer’s Disease Drug
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.
Biogen Ends Aduhelm Study Due to Medicare Restrictions
Biogen has ended its observational ICARE AD real-world data (RWD) trial for Aduhelm, another in a long series of setbacks [...]
Roche’s Amyloid-Targeting Alzheimer’s Drug Fails in Phase II Trial
Roche and Genentech released data from their Phase II API-ADAD trial showing their experimental Alzheimer’s disease drug crenezumab failed to [...]
Lack of Funding and COVID Outbreaks Sank Chinese Drugmaker’s Alzheimer’s Phase III Trial
Green Valley Pharma has ended its Phase III clinical trial for its Alzheimer’s drug due to funding issues and new [...]
Access to Alzheimer’s Drugs in Question Due to Medicare Draft Coverage
The draft guidance released by the Centers for Medicare and Medicaid Services (CMS) regarding coverage for the Alzheimer’s drug Aduhelm [...]
Alzheimer’s Advocates Ask US Govt to Approve Aduhelm Medicare Reimbursement
In response to Medicare’s decision to only cover the Alzheimer’s drug Aduhelm in clinical trials, patient advocacy groups have begun [...]
Abbvie Purchases Syndesi Therapeutics for its Alzheimer’s Expertise
Abbvie has purchased Syndesi Therapeutics in a $1 billion deal. The drugmaker seeks to access Syndesi’s research into treating cognitive [...]
Experts in Alzheimer’s Recommend Accelerated Withdrawal for Aduhelm
A group of medical professors and expert researchers in Alzheimer’s disease have asked the FDA to quickly withdraw their approval [...]
Former HHS Secretary Calls for Investigation into FDA’s Aduhelm Approval
Former Secretary of Health and Human Services (HHS) Donna Shalala has called for an investigation into the widely criticized Aduhelm [...]
Alzheimer’s Association Calls on Biogen to Lower Aduhelm’s Price
The Alzheimer’s Association is the latest group to call on Biogen to lower the price of Aduhelm, its controversial Alzheimer’s [...]
Healthcare Policy Experts Urge CMS to Quickly Move on Biogen’s Alzheimer’s Drug
The Food and Drug Administration has approved Biogen’s aducanumab drug for Alzheimer’s disease. Several health policy experts are calling for [...]
Draft Scoping Document for the Assessment of Alzheimer’s Disease Posted by ICER
Yesterday the Institute for Clinical and Economic Review (ICER) posted a Draft Scoping Document detailing the planned review of the comparative clinical effectiveness [...]
