Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug.
FDA reviewers had previously assessed the drug’s prospects more positively.
The company is preparing for the event of an FDA approval of the drug in June.
Biogen’s CEO Michel Vounatsos said in an analyst call today that he expects the antibody drug to sell well given the surging numbers of Alzheimer’s patients in the U.S. and elsewhere. “We anticipate if approved, there will be a large influx of patients,” Vounatsos concluded.
The company has argued that aducanumab slows disease progression in Alzheimer’s patients, which is a feat that no other FDA-approved drug can manage. But critics have argued that the company has failed to demonstrate that the drug is effective and have expressed concern over the drug’s potential to cause amyloid-related imaging abnormalities (ARIA).
Earlier this year, FDA announced that it had extended the review period for aducanumab by three months to June 7, 2021, and that it had requested additional data related to the antibody.
UBS analysts have speculated that FDA’s request for more information regarding the drug was related to safety questions.
In a March briefing note, UBS analysts concluded that senior FDA officials are likely overseeing the drug review given the drug candidate’s “high profile” and the “atypical regulatory process” involved.
Several financial analysts have concluded that the aducanumab has a roughly 50/50 chance at FDA approval. If the agency listens to feedback from the Peripheral and Central Nervous System Advisory Committee, it could recommend that Biogen launch a new Phase 3 trial of the drug.
The company has already launched two Phase 3 studies of the drug. Both were stopped early. One trial seemed to show no benefits from the drug, while the other indicated it was effective. After further reviewing the data, Biogen concluded that the patients receiving adequately high doses of aducanumab saw benefits in both clinical trials.
Aducanumab is similar to Eli Lilly’s donanemab in its amyloid in Alzheimer’s disease. Several pharmaceutical companies have been inspired by the amyloid hypothesis, which holds that the protein fragment beta-amyloid is toxic to the brain and is thus responsible for Alzheimer’s.
Donanemab, like aducanumab, has had mixed clinical trial data results to date.
Given the substantial Alzheimer’s patient population and shortage of treatments available for the disease, the Alzheimer’s Foundation has supported FDA approval of aducanumab.