Biogen to Start Re-dosing Aducanumab in Alzheimer’s Patients From Halted Trials

Biogen to Start Re-dosing Aducanumab in Alzheimer’s Patients From Halted Trials
Biogen will soon launch an open-label trial to start re-dosing aducanumab  — an injectable treatment under development — to patients with Alzheimer’s disease who participated in four studies halted in March 2019. The company said it submitted the protocol of the re-dosing study to the U.S. Food and Drug Administration, and is working with U.S. trial sites to begin re-dosing in March. The trial does not include a placebo-controlled arm, according to a Biogen website. Biogen is "actively working in Europe and Japan to reopen sites there, and will then engage in other markets around the world, which requires seeking approval by regional regulatory authorities and institutional review boards," the company confirmed in an email to Alzheimer's News Today. As sites open, physicians or study coordinators will contact previously enrolled patients to share more details and advise on appropriate steps for enrollment, Biogen said. The Phase 3 open-label trial (NCT04241068) will offer a re-dosing of aducanumab to patients who were actively enrolled in the aducanumab trials when they were halted. Those were ENGAGE (NCT02477800), EMERGE
Subscribe or to access all post and page content.