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Biogen moves forward with potential Alzheimer's drug, seeks U.S. approval

By Manojna Maddipatla

(Reuters) - Biogen Inc said on Wednesday it submitted an application seeking U.S. approval of its closely watched Alzheimer's drug, as the company aims to be the first to bring a treatment to market that can alter the course of the mind-wasting disease.

Biogen shares were up nearly 5% at $281.34 in afternoon trading on the Nasdaq.

The number of people in the United States living with Alzheimer's, the most common form of dementia, is expected to triple to nearly 14 million by 2050 without effective treatments, according to the U.S. Centers for Disease Control and Prevention. If approved, Biogen's aducanumab would be the first treatment designed to delay progression of the fatal, memory-robbing disease.

The drug has had a tumultuous journey, with promising early data raising hopes and Biogen's share price, only to be dashed by disappointment in later trials.

Biogen in October revived plans to seek approval for aducanumab based on a detailed analysis of what had seemed like less than compelling data, months after scrapping its development.

The biotech company said its analysis showed patient improvements in memory and other measures of cognition and ability to function. Some experts have expressed skepticism over Biogen's interpretation of the data and called for another large trial that could take several years to complete.

Wall Street analysts have been betting on aducanumab to restore Biogen's growth prospects following a successful patent challenge to its top-selling multiple sclerosis drug Tecfidera and with looming competition for its high-priced gene therapy Spinraza weighing on its shares.

However, the drug's approval is far from guaranteed despite the desperate need for treatments. It has been at least 15 years since the Food and Drug Administration has reviewed an application for a new Alzheimer's treatment, as drugs that were tested failed in trials.

Dr. Maria Carrillo, chief science officer at the Alzheimer’s Association advocacy organization, declined to comment on the chances of the drug winning approval, saying, "That really is up to the FDA."

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