Donanemab Outperforms Aducanumab in Amyloid Clearance, FDA Grants Priority Review to SRP-9001, Atogepant Improves PROs


Neurology News Network for the week ending December 3, 2022. [WATCH TIME: 3 minutes]

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

In the first ever head-to-head study between donanemab (Eli Lily), an investigational antibody therapy, and aducanumab, a recently approved medication for patients with early Alzheimer disease (AD), findings showed that donanemab outperformed aducanumab in terms of amyloid clearance.The findings, presented at the 2022 Clinical Trials on Alzheimer Disease (CTAD) conference, held November 29 to December 2, in San Francisco, California, were from the pivotal phase 3 TRAILBLAZER-ALZ 4 study (NCT05108922). Using flortaucipir F18 PET scans, 37.9% of donanemab-treated participants achieved amyloid clearance at 6 months compared with 1.6% of those on aducanumab (<.001). The safety profiles of each therapy, including the incidence of amyloid-related imaging abnormalities (ARIA), were similar. Aducanumab, an anti-amyloid therapy, made history in 2021, making it the first novel approval for the neurodegenerative condition since 2003. Under the accelerated approval pathway, aducanumab’s approval was based off its ability to reduce amyloid-ß (Aß) plaques.

According to a recent announcement, the FDA accepted and granted priority review to Sarepta Therapeutics’ biologics license application (BLA) for SRP-9001, an investigative gene therapy for treating Duchenne muscular dystrophy (DMD), with a PDUFA date set for May 29, 2023. Developed in partnership with Roche, SRP-9001 is designed to express microdystrophin to combat the deleterious effects of the dysfunctional dystrophin produced in DMD. It has been granted fast track, rare pediatric, and orphan drug designations in the US as well as orphan drug status in the EU, Switzerland, and Japan. Of note, the BLA was submitted using the accelerated approval pathway in September 2022.

Recently published findings showed that atogepant (Qulipta; AbbVie), an FDA-approved preventive for episodic migraine, significantly improved patient-reported outcomes (PROs) that assessed functioning in daily social and work-related activities, as well as emotional impact, physical impairment, and overall impact of headaches. Led by Richard B. Lipton, MD, director of the Montefiore Headache Center, the post-hoc analysis specifically focused on several PROs, including the Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ v2.1), Activity Impairment in Migraine-Diary (AIM-D), and Headache Impact Test-6 (HIT-6). The study was designed with a 4-week baseline period, 12-week double-blind treatment period, and 4-week safety follow-up period. Each patient took treatment once daily, orally, at approximately the same time each day.

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