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Biogen CEO with reasonable confidence in Alzheimer's drug will get FDA approval



Biogen CEO Michel Vounatsos on Wednesday told CNBC that he is "reasonably confident" that the US Food and Drug Administration will approve drug makers' experimental Alzheimer's drug.

"We worked with the regulator in full transparency," Vounatsos told "Squawk Box," emphasizing that the FDA has all of the company's data on the drug.

"The evidence came over time. We gathered a huge and complex set of data, including biomarkers and imaging," he said. "This was a thorough commitment and as CEO I am reasonably confident that this will lead to market approval someday."

Shares of Biogen rose more than 26% on Tuesday after the drug maker shocked investors by announcing that it sought government approval for the once-failed Alzheimer's drug, aducanumab. The shares were about 2% higher in Wednesday's premarket.

In March, the Cambridge, Massachusetts-based company said it stopped two late-stage attempts for its drug after an analysis by an independent review revealed that the drug was unlikely to work. [1

9659002] Biogen lost billions of dollars in market value at that time. The scientific community saw the announcement as a setback after spending billions on researching and developing possible treatments – with almost nothing to show for it. Patients and families living with the disease that had pinned hope for aducanumab were heartbroken.

Alzheimer's disease can cause people's memory and minds to deteriorate to a point where they cannot function on their own and eventually die. It is the sixth leading cause of death in the United States, and the Alzheimer's Association estimates that 5.8 million Americans live with the disease.

There are currently no approved medications that can reverse the mental decline of Alzheimer's. The FDA has approved Alzheimer's medication aimed at helping symptoms, not reversing or curbing the disease itself.

Biogen's experimental drug targets a compound in the brain known as beta-amyloid, which was believed by many scientists and drug addicts to play a role in the devastating disease by eroding synapses between nerve cells.

On Tuesday, Biogen said a new analysis of a larger data set showed that aducanumab "reduced clinical decline in patients with early Alzheimer's disease" and patients receiving the drug "experienced significant benefits on recognition and function measures such as memory, orientation, and language. "

The findings were met with skepticism from investors who say the results may have been a coincidence. However, the stock rose anyway in hopes of approval.

Vounatsos insisted that Biogen's dosage of the drug previously just wasn't high enough. "The road to groundbreaking innovation if it is full of twists and turns," he added. "We started to have some hope."


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