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Trending Topics & Drug Approvals: May 2025

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June 4, 2025

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The United States (U.S.) Food and Drug Administration (FDA) has cleared for marketing the first blood test to aid in diagnosing Alzheimer’s disease (AD): Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. The test measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma and is for early detection of amyloid plaques associated with AD in patients ≥ 55 years of age with signs and symptoms. The numerical ratio of the two proteins is calculated and then correlated to the presence or absence of amyloid plaques in the patient’s brain. In contrast to other FDA-cleared tests that require cerebrospinal fluid (CSF) samples taken via lumbar puncture, only a blood draw is required for Lumipulse. Clinical study results included 499 individual plasma samples and demonstrated that Lumipulse can reliably predict amyloid pathology associated with AD in patients who are cognitively impaired. A total of 91.7% of patients with positive results had the presence of amyloid, and 97.3% of patients with negative results were negative for amyloid based on positron emission tomography (PET) scan or CSF test results. Lumipulse is not intended for use as a screening or standalone diagnostic. Results require interpretation in conjunction with other patient clinical information (e.g., clinical evaluations, additional tests); the new blood test may reduce the need for a PET scan in patients with signs and symptoms of cognitive decline. Fujirebio Diagnostics’ Lumipulse received Breakthrough Device Designation and was reviewed through the 510(k) premarket notification pathway. 

The FDA has issued a Drug Safety Communication on the risk of severe itching (pruritus) following discontinuation of long-term daily use of oral allergy medications (e.g., cetirizine [Zyrtec], levocetirizine [Xyzal]). The product labeling for prescription cetirizine and levocetirizine will be updated to include a new warning regarding this risk, and manufacturers of over-the-counter products will be required to make corresponding updates to the Drugs Fact Label. A total of 209 worldwide cases (197 in the U.S.) were reported to the FDA between April 2017 and July 2023. Many patients reported widespread pruritus requiring medical intervention. Although the overall incidence is rare and the mechanism is unknown, the FDA concluded there is a causal relationship between discontinuation of these medications and pruritus. Apart from prolonged use, the FDA has not identified any risk factors following discontinuation. Furthermore, restarting the medication resolved the pruritus in the majority of individuals, and some were able to taper off these medications with continued symptom resolution.    

The U.S. Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics published a data brief on the prevalence of depression in adolescents and adults in the U.S. from August 2021 to August 2023. Depression was defined by a score of ≥ 10 on the 9-item Patient Health Questionnaire (summary scores, 0 to 27), which is a validated screening instrument for self-reported depressive symptoms. The overall prevalence of depressive symptoms in individuals ≥ 12 years of age in the prior two weeks was 13.1%. Prevalence decreased as patient age increased and was highest in those 12 to 19 years of age (19.2%) and lowest in adults ≥ 60 years of age (8.7%). The prevalence of depression also decreased as family income increased. Females (16%) exhibited a higher prevalence than males (10.1%) for all age groups with the exception of ages 20 to 39 years (19% versus 14.3%, respectively) where the difference was not significant. In adolescents 12 to 19 years of age, prevalence in females was more than twice that in males in the same age range (26.5% versus 12.2%). From 2013-2014 to August 2021-August 2023, the prevalence of depression increased similarly for females and males ≥ 12 years of age from 8.2% to 13.1%. The majority of individuals (87.9%) with depression reported challenges with work, home or social activities due to symptoms of their depression. However, only 39.3% of patients with depression received counseling or therapy from a mental health professional in the prior 12 months, with more females (43%) than males (33.2%) receiving these services.

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