Two health care companies – one based in Massachusetts called Biogen and its Japanese partner Eisai Co. – recently were granted “fast track” approval by the U.S. Food and Drug Administration (FDA) for their experimental therapy named lecanemab.
The drug developed by Biogen and Eisai is meant to bind to the protein amyloid-beta – a toxic protein found in unusual amounts in the brains of Alzheimer’s patients – helping to get rid of that protein in the initial stages of the disease to mitigate its impact.
Timeline for the drug
The first clinical study for the drug started in March 2019. From there, the FDA granted lecanemab breakthrough therapy designation – a process designed to expedite the review of drugs – in June 2021. This allowed the companies to start submitting portions of their application as it was finished, versus waiting for the entire application to be done before handing it to the FDA.
“The lecanemab rolling biologics license application (BLA) submission marks a new milestone toward the advancement of a treatment system for Alzheimer’s disease,” Haruo Naito, Eisai’s CEO, said in a press release. “We are committed to bringing new medicines to people living with Alzheimer’s and their families as early as possible.”
The biologics license application Naito is referring to is based on data from the company’s proof-of-concept Study 201, which included 856 patients with mild cognitive impairment (MCI) and mild Alzheimer’s disease.
The data showed that lecanemab reduced amyloid-beta clumps in the brain and slowed clinical decline at 18 months of treatment.
What does fast track status mean?
Fast track status is a process meant to speed up the review of treatments and vaccines for serious conditions and fill an unmet medical need, according to the FDA. In other words, the process is supposed to get new drugs to patients earlier and faster.
Because Biogen and Eisai were granted fast track status in December 2021, they are eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure appropriate data is received to support the drug’s approval.
“Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication ensures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients,” said the FDA.
Where does the drug stand today?
Under the FDA’s accelerated approval program, the drug must also be tested in supporting clinical trials with more patients to verify the therapy provides clinical benefits shown in the earlier-phase studies.
A Phase 3 clinical trial, called Clarity AD, will test the effectiveness of the experimental drug as a possible treatment for Alzheimer’s. Specifically, it will go on for 18 months and use up to 1,766 participants between the ages of 50 to 90 that have mild MCI or mild AD.
The FDA agreed the trial will serve to verify the clinical benefits of lecanemab, as stated by Eisai. Initial data for the study is predicted to be available by the end of September this year with the study expecting to finish around March 2024.