(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…
“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. We are looking
forward to that rigorous review and their decision. [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.”
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.