Present estimates show that 6.5 million US individuals are living with Alzheimer's disease, and calculations propose the number can triple in just a few decades. The huge, anticipated increase is associated with an aging population, lifestyle risk factors, and chronic disease. Cases among younger individuals may also be increasing. With these considerations and the knowledge that, historically, studies have not had full information regarding incidence in all countries, the actual number of global instances may even be much higher than the present estimate of 50 million. New treatments to help slow the life-threatening disease's effects are in critical demand.
Earlier detectable symptoms of Alzheimer's disease include mild cognitive impairment. Thoughts, memories, and language skills are affected, and the patient's quality of life degrades. The condition becomes dangerous when progression occurs and physical functionality is impacted. Immobility with resulting infections and issues with swallowing and aspiration are the usual circumstances that lead to death.
There is no cure for Alzheimer's disease. Most of the common treatments work to regulate neurotransmitters, which aids in some cases of memory loss and behavioral issues. For mild-to-moderate disease, donepezil, rivastigmine, and galantamine are used to combat symptoms. Individuals with moderate-to-severe disease are commonly prescribed donepezil, memantine, the rivastigmine patch, or a donepezil/memantine combination. While these drugs are helpful for many patients, the development of and access to effective and safe therapy that goes beyond symptomatic treatment and instead delays or slows the degradation and death of brain cells is a desirable goal.
The recent approval of Leqembi (lecanemab) marks a significant milestone in reaching that goal. Fast-tracked for approval in January of this year and then granted full approval by the FDA in July 2023, lecanemab is now the first immunotherapy with this clearance. Prior to this, the disease-modifying therapy Aduhelm (aducanumab) was granted accelerated approval by the FDA in June 2021. However, without full approval and debated effectiveness, coverage for and use of the drug has remained limited.
Lecanemab targets the amyloid-beta protein as it begins to form fibers that accumulate as plaques in the brain. Accumulation of the abnormal structures results in adverse effects on brain function. By mimicking the response of human antibodies to clear the protein from brain tissues, monoclonal antibodies like lecanemab work to modify the pathophysiology of Alzheimer's disease. It is not a cure for the disease, but it is able to slow down the memory and thinking decline in patients during the early stages.
The government has established labeling, prescribing, and coverage parameters for lecanemab due to concerns connected to rare but serious adverse effects, specifically amyloid-related imaging abnormalities (ARIA). The drug's prescribing information includes a boxed warning to alert providers, patients, and caregivers about the potential risks associated with ARIA. The prescribing information also stipulates that before beginning treatment with lecanemab, patients must complete diagnostic testing to confirm the presence of amyloid-beta proteins. Additional genetic testing is also recommended for identifying what version of the ApoE gene a patient carries. Research has indicated that individuals who carry ApoE e4 have a higher risk of serious side effects with lecanemab. For Medicare patients to receive coverage, those prescribed lecanemab must be enrolled in a qualifying registry, such as the CMS-facilitated registry now open for clinicians to access.
To make a significant difference for patients with Alzheimer's disease, access to approved therapies needs to increase. Accomplishing this while protecting patient safety is necessary. As the clinical practice for treating Alzheimer's disease continues to evolve, stay informed about critical drug information, including targeted therapies for Alzheimer's disease, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, available for free from your preferred app store.
Latest FDA News
FDA New Approvals
The FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Learn more about Elrexfio
The FDA has approved Eylea HD (aflibercept) injection 8mg for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.Learn more about Eylea HD
The FDA has approved Hepzato (melphalan) for injection, a component of the Hepzato Kit Hepatic Delivery System, for intra-arterial use as a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.Learn more about Hepzato
The FDA has approved Izervay (avacincaptad pegol) intravitreal solution for the treatment of geographic atrophy, the advanced form of dry age-related macular degeneration. Learn more about Izervay
The FDA has approved Sohonos (palovarotene) capsules for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva. Learn more about Sohonos
The FDA has granted accelerated approval of Talvey (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Learn more about Talvey
The FDA has approved the biosimilar Tyruko (natalizumab-sztn). Tyruko is approved to treat all indications covered by the reference medicine, Tysabri (natalizumab), and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis. Learn more about Tyruko
The FDA has approved Veopoz (pozelimab-bbfg) for the treatment of adult and pediatric patients aged 1 year and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE. Learn more about Veopoz
The FDA has approved Zurzuvae (zuranolone) 50mg for adults with postpartum depression (PPD). Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023, shortly following scheduling as a controlled substance by the DEA, which is anticipated to occur within 90 days.Learn more about Zurzuvae
FDA New Indications
The FDA has approved Abrysvo (respiratory syncytial virus vaccine) for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus in infants from birth up to six months of age by active immunization of pregnant individuals at gestational age 32 through 36 weeks.Learn more about Abrysvo
The FDA has approved the first therapeutic indication for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults. Daxxify was previously approved for the temporary improvement of glabellar lines (frown lines) in adults.Learn more about Daxxify
The FDA has approved an expanded indication for Ervebo (Ebola Zaire vaccine, live), which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals aged 12 months and older. The vaccine was previously approved for use in individuals aged 18 years and older.Learn more about Ervebo
The FDA has approved Ingrezza (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease. Learn more about Ingrezza
The FDA has approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions. This expanded indication to the first-line setting is based on interim results from the pivotal Phase 3 COMMANDS trial.Learn more about Reblozyl
The FDA has approved Tafinlar (dabrafenib), in combination with trametinib, for the treatment of adult and pediatric patients aged 1 year and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. The FDA has also approved Tafinlar (dabrafenib), in combination with trametinib, for the treatment of pediatric patients aged 1 year and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.Learn more about Tafinlar
FDA New Combinations
Lonsurf + Bevacizumab
The FDA has approved Lonsurf (tipiracil/trifluridine) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.Learn more about Lonsurf + bevacizumab
Akeega + Prednisone
The FDA has approved the combination drug regimen for Akeega (abiraterone acetate; niraparib), the first-and-only dual-action tablet combining a poly (ADP-ribose) polymerase inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer, as detected by an FDA-approved test.Learn more about Akeega + prednisone
FDA Recalls & Alerts
Dr. Berne's MSM Eye Drops
Dr. Berne's Whole Health Products is voluntarily recalling all lots of MSM drops 5%,15% solution, Dr. Berne's organic castor oil eye drops, and Dr. Berne's MSM mist 15% solution, to the consumer level. FDA analysis has found one lot (lot 6786) of Dr. Berne's MSM drops 5% solution to fail sterility with both bacterial and fungal contamination found in the product. Out of an abundance of caution, Dr. Berne's is recalling all other lots of the 5% and 15% strengths of MSM solution, and all lots of Dr. Berne's organic castor oil eye drops and Dr. Berne's MSM mist 15% solution.Learn more about the Dr. Berne's MSM eye drops recall
Inmar Supply Chain Solutions Products
Inmar Supply Chain Solutions is voluntarily recalling FDA-regulated products contained in pallets stored in Inmar's Arlington, Texas facility between May 1, 2022, and June 30, 2023. FDA-regulated products include food, over-the-counter human or animal drugs, over-the-counter medical devices, dietary supplements, and/or cosmetics, medical devices such as diapers, toothbrushes, feminine hygiene products, and condoms. The products were stored in this facility when there may have been a pest control problem at the facility. In addition, because of recent unusually hot weather, the products may have been subjected to temperatures above the storage condition instructions on the product labeling.Learn more about the Inmar Supply Chain Solutions products recall
Marlex Pharmaceuticals Digoxin
Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of digoxin tablets USP, 0.125mg and one lot of digoxin tablets USP, 0.25mg (lot# E3810 and lot# E3811), to the consumer level, due to a label mix-up. Bottles of digoxin tablets, USP 0.125mg are incorrectly labeled and contain digoxin tablets USP, 0.25mg tablets. Bottles of digoxin tablets USP, 0.25mg are incorrectly labeled and contain digoxin tablets USP, 0.125mg. Learn more about the Marlex Pharmaceuticals digoxin recall
Wefun Dietary Supplements
Wefun Inc. is voluntarily recalling 300 boxes of Wefun capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. The presence of sildenafil in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.Learn more about the Wefun dietary supplements recall
Methylsulfonylmethane (MSM) Eye Drops
The FDA is warning consumers not to purchase and to immediately stop using Dr. Berne's MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both. Dr. Berne's products were distributed by Dr. Berne's Whole Health Products; LightEyez's products are distributed by LightEyez Limited. Dr. Berne's Whole Health Products voluntarily recalled Dr. Berne's MSM Drops 5% and 15% Solution Eye Drops due to bacterial and fungal contamination.Learn more about the MSM eye drop alert
Labeling Updates - No Updates this Month
*Warnings and Precautions; Adverse Reactions; Drug Interactions; and Contraindications