Neurology News Network: Notable FDA Approvals From 2025

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I'm Marco Meglio. As 2025 wraps up, we decided to highlight 3 of the biggest FDA decisions that came during this year.

In early March, the FDA approved tenecteplase (TNKase; Genentech) for the treatment of acute ischemic stroke (AIS) in adults. The thrombolytic medicine is an intravenous (IV) tissue plasminogen activator that is clot-dissolving, administered as a single 5-second IV bolus. The company noted that it will be providing a 25-mg vial configuration in the coming months to support the approval. Tenecteplase’s approval was based on the data collected from the phase 3 AcT trial (NCT03889249), which enrolled 1600 patients and compared outcomes between patients treated with the new therapy compared with alteplase. The data showed that 36.9% of those treated with tenecteplase (296 of 802) reported modified Rankin Scores (mRS) of 0-1 in the 90- to 120-day window compared with 34.8% of the alteplase group (266 of 765), showing noninferiority and an unadjusted risk difference of 2.1%.

Months later, the FDA 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.

The FDA has approved a new autoinjector formulation for lecanemab (Leqembi; Eisai), an antiamyloid therapy indicated for patients with early-stage Alzheimer disease (AD) and mild cognitive impairment (MCI) from AD. With the decision, the subcutaneous autoinjector (SC-AI) becomes the first-ever at-home, self-administered option for ongoing AD treatment, improving convenience and access for patients in the United States. The new SC-AI, approved based on data from the pivotal phase 3 Clarity AD trial (NCT03887455), provides quicker administration for patients, lasting about 15 seconds total. In clinical trial settings, it demonstrated comparable exposure, improved tolerability, enhanced amyloid clearance, and better user-friendliness in patient, caregiver, and healthcare surveys. In addition, there is a belief that this new SC-AI will have significant societal cost savings, lowering treatment and administration expenses.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.

REFERENCES
1. FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults. News release. Genentech. March 3, 2025. Accessed December 22, 2025. https://www.gene.com/media/press-releases/15053/2025-03-03/fda-approves-genentechs-tnkase-in-acute-
2. FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. News release. Teva Pharmaceuticals. August 6, 2025. Accessed December 22, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment/
3. FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease. News release. August 29, 2025. Accessed December 22, 2025. https://www.prnewswire.com/news-releases/fda-approves-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-for-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease-302542371.html