Biogen Inc. (NASDAQ: BIIB), a U.S. drug company, has announced that the first therapy that could slow Alzheimer’s disease may be nearly ready to release to market. The company plans to file the paperwork for regulatory approval for its drug, aducanumab, in the U.S. in early 2020, as well as in Europe at a later date. The approval processes could take a year or two before the drug is ready for market.
The announcement was a surprise to many. Just months ago, Biogen discontinued clinical studies of the same drug after a data analysis showed disappointing results, but resurrected the drug after additional analyses suggested it might have some effect at higher doses. Wall Street was expecting this drug to be the company’s next big source of revenue.
Biogen now says the drug may help slow cognitive decline in certain patients with mild cognitive impairment and the earliest signs of Alzheimer’s disease. Aducanumab is a monoclonal antibody, a type of drug that attaches to specific proteins in order to disable them. It specifically targets a protein called amyloid that forms abnormal deposits the brains of people with Alzheimer’s.
A new analysis of a larger dataset of the same studies showed that higher doses of aducanumab could provide a significant benefit to patients with early Alzheimer’s. The hope was that if patients were treated early in the course of the disease, it would slow their clinical decline so they would retain more of their memory and everyday living skills. The company says that about 10 million Americans might qualify for treatment if the drug were approved.
Prior to the drug announcement, Biogen reported third-quarter earnings that beat Wall Street estimates. The drugmaker reported earnings per share of $9.17, a 7.1 percent increase from the same period the previous year. Analysts had forecast earnings of $8.27 per share. Revenue was reported at $3.60 billion, 5 percent higher than the year before and more than analysts’ estimates of $3.54 billion.