Elecsys Blood Test Gains EU Approval, FDA Expands Fremanezumab Indication Into Pediatrics, VX-993 Fails Phase 2 Pain Trial

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

According to a new announcement, Roche’s Elecsys pTau181 test, a blood test geared to rule out Alzheimer disease (AD) diagnosis from other cognitive declines, has gained CE Mark, opening access for those who live in the European Union. The blood test, approved in the U.S. in 2022, is an automated, in-vitro diagnostic assay that measures phosphorylated tau (p-Tau)181, a key biomarker of amyloid pathology and one of the two hallmark proteinopathies in AD. It serves as a rule-out tool: a negative result reliably indicates no amyloid pathology, reducing the need for PET scans or lumbar punctures. Through this simple blood test, clinicians may better triage and manage cognitive declines earlier.

The FDA has approved an expanded indication for Teva’s fremanezumab (Ajovy) to include the preventive treatment of pediatric patients with episodic migraine aged 6-17 who weigh 45 kilograms or more. With the approval, fremanezumab becomes the first anti-calcitonin gene-related peptide (CGRP)-targeting treatment approved for both pediatric episodic migraine prevention and migraine prevention in adults. The expanded indication into pediatrics was based on data from the phase 3 SPACE study (NCT03539393), a double-blind, placebo-controlled, parallel-group study of pediatric patients with history of less than 14 headache days a month. SPACE, which comprised 237 pediatric patients aged 6-17, showed that fremanezumab treatment resulted in statistically significant superior efficacy over a 12-week period compared with placebo, while maintaining a safety profile that was consistent with prior observations.

According to recently announced data from a pivotal, placebo-controlled, dose-ranging phase 2 trial of patients with acute pain, Vertex Pharmaceuticals’ VX-993 failed to differentiate itself against placebo in the primary end point of time-weighted Sum of the Pain Intensity Difference (SPID). Based on these findings, the company will discontinue the development of this agent as a monotherapy for acute pain. This large-scale study comprised 367 patients with acute pain following bunionectomy surgery who were randomly assigned to 1 of 5 different arms. The primary end point, change in SPID over the first 48 hours of treatment, was recorded through the Numeric Pain Rating Scale. In comparison with placebo, the mean SPID48 difference in the high-dose, mid-dose, and low-dose VX-993 groups were 24.3 (95% CI, –6.3 to 54.9; P = .1190), 21.2 (95% CI, –8.7 to 51.2; P = .1643), and 3.7 (95% CI, –26.7 to 34.1; P = .8094), respectively.

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