In February, 2021, Fierce Pharma released its report of the 10 most-anticipated drug launches of 2021, which ranks drugs based on predicted global sales through 2026. The report’s most anticipated drug is aducanumab, which is produced by Biogen and Eisai for the treatment of Alzheimer’s disease.
The drug’s release, however, is still awaiting approval – or rejection – by the U.S. Food and Drug Administration (FDA). There is significant debate over whether the drug makes a difference in Alzheimer patients after a series of clinical trials show mixed results. If approved, the drug is expected to cost about $50,000 per patient, per year.
The FDA was originally expected to make a decision on the drug application on March 7, 2021, but that date has now been pushed back three months to June 7, 2021.
The drug did not perform well in a November Advisory Committee (AdComm) meeting with all but one committee member voting down the drug after reviewing two phase 3 studies and hearing testimony. However, eight months later, Biogen argues that the analysis was incorrect, and the drug does show efficacy in patients who received a high dose of the drug. This has led the company to move forward with its filing for approval.
According to Fierce Pharma, if the drug is approved, it is expected to reach nearly $5 billion in sales by 2026.