Alzheimer's new drug application! Biogen plans to submit aducanumab application in early 2020

Biogen and Eisai today announced that in consultation with the U.S Food and Drug Administration (FDA), Biogen plans to seek regulatory approval for a new drug, aducanumab, for the treatment of early Alzheimer's disease (AD) In the phase 3 study of emerge, aducanumab reached its primary end point Biogen believes that some patients in the phase 3 engage study received high dose of aducanumab, which supports the findings of emerge Patients who received aducanumab showed significant improvement in cognition and function (such as memory, orientation, and language) Patients also benefit from activities of daily living, including personal finance, household chores (such as cleaning, shopping and laundry), and independent travel If approved, aducanumab will be the first therapy to reduce the clinical decline of Alzheimer's disease, and also the first therapy to prove that the removal of amyloid β can bring better clinical results "Because this devastating disease affects tens of millions of people around the world, today's announcement is really exciting in the fight against Alzheimer's It's the result of a breakthrough study, and it's a testament to Biogen's determination to follow science and do the right thing for patients, "said Michel vounatsos, CEO of Biogen "We hope to provide patients with the prospect of the first therapy to reduce the clinical decline of Alzheimer's disease, and the potential impact of these results on similar approaches to amyloid beta." Biogen plans to submit the application for permission to market of biological products (BLA) of aducanumab to the FDA in early 2020, and actively negotiates the hope of listing in Europe and Japan (Bio Valley / bio Com) original source: Biogen official website