Shares of Biogen soared Tuesday after the biotechnology company said it is seeking regulatory approval for an early Alzheimer's treatment drug. The surprise announcement, which sent shares up nearly 40 percent in early trading hours, comes months after the company discontinued its research on the drug and has sent a wave of optimism through those affected by the disease.
Biogen said that after receiving new data, the company determined that its test patients who received the treatment — called aducanumab — did show signs of improved cognitive and functional capabilities. If accepted by the U.S. Food and Drug Administration, aducanumab will be the first approved treatment that reduces the effects of Alzheimer's.
"With such a devastating disease that affects tens of millions worldwide, today's announcement is truly heartening in the fight against Alzheimer's," said Biogen's CEO Michel Vounatsos.
In March, Biogen ($BIIB) halted its trial of aducanumab because the drug failed the so-called "futility analysis," which suggested a clinical trial would fail to achieve its objectives. The discontinuation sent the company's stock plummeting at the time. New data, however, later became available that provided researchers with a larger dataset that showed different, far more positive results.
Biogen said that patients who received high doses of aducanumab experienced significant improvements in their cognition abilities, like memory and orientation, and greater functional capabilities, which eased daily activities like shopping, cleaning, and traveling independently. The company had been developing the treatment in collaboration with Eisai, a Japanese pharmaceutical company, since October 2017.
"There is tremendous unmet medical need, and the Alzheimer's disease community has been waiting for this moment," said Dr. Anton Porsteinsson, the director of the Alzheimer's Disease Care, Research, and Education Program at the University of Rochester and a principal investigator in Biogen's study.
First diagnosed in 1906, Alzheimer's is a devastating brain disease that has vexed the medical and pharmaceutical communities for decades.
In June, for instance, Pfizer came under pressure after reports surfaced claiming that the biopharmaceutical giant chose not to pursue clinical trials after internal researchers determined that one of the company's popular drugs may also reduce the risk of Alzheimer's. Pfizer claimed that the decision was made because a clinical trial was unlikely to succeed. Critics, however, accused the company of not pursuing a promising lead to avoid more costly research.
In 2018, an estimated 5.7 million Americans were living with Alzheimer's, according to the Alzheimer's Association. The vast majority of patients are over 65 years old but roughly 200,000 people last year were afflicted with younger-onset forms of the disease.
"We have never been as optimistic as we are today," the Alzheimer's Association, which supports Alzheimer's care and research nationwide, said in a statement Tuesday. "We eagerly anticipate reviewing a full report of [Biogen's] findings from these studies."
