|
 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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"We are looking forward to that rigorous review and their decision," Carrillo
said, adding that a "drug like this that addresses the biological causes
associated with Alzheimer's dementia would be historic and no doubt impactful
for the Alzheimer's community."
Prior to the focus on COVID-19 vaccines and treatments, the wait for
aducanumab's filing and approval was probably the most-watched saga to play out
in biopharma this year, SVB Leerink analyst Marc Goodman said.
The FDA now has 60 days to decide whether to accept the application for review,
Biogen and partner Eisai Co Ltd said in a joint statement.
"It is unclear to us if the totality of the data support FDA approval. Just as
there are signs of activity, there are inconsistencies in the data that raise
questions about aducanumab's biologic effect," Cowen analyst Phil Nadeau said.
Biogen said it has asked for a "priority review" for the drug that could cut the
time for an approval decision to six months, if granted.
Any successful Alzheimer's treatment is expected to eventually be a
multibillion-dollar seller. Analysts are forecasting aducanumab sales of $673.7
million in 2022 if approved, according to Refinitiv IBES estimates.
Biogen said it was also working toward submitting marketing applications for the
drug in Europe, Japan and elsewhere.
(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Bill
Berkrot and Jonathan Oatis)
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