Biogen has picked up a US Food and Drug Administration (FDA) fast-track review for its experimental Alzheimer’s disease treatment aducanumab.
The drug application has been granted a priority review with a prescription drug user fee act (PDUFA) action date due on 7 March 2021. The FDA stated that, if possible, it will act early on this application under an expedited review.
If approved, aducanumab will become the first treatment to reduce the clinical decline of Alzheimer’s disease, which affects around six in every ten people with dementia in the UK, according to Alzheimer’s Research UK.
The FDA has agreed to accelerate the review without the use of a priority review voucher, which guarantees the expedited review of a drug application. The agency is also planning to hold an advisory committee meeting of outside experts to discuss the application on a yet-to-be-determined date.
“The FDA’s acceptance of the aducanumab biologics license application with priority review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, chief executive officer at Biogen.
“We look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and have accompanied us on this journey,” he added.
The road to approval has been a rocky one for Biogen’s drug, with many twists and turns along the way.
Last October, the company said that it planned to file aducanumab only a few short months after abandoning the drug in phase 3. The drug was initially scrapped following advice from an independent data monitoring committee to halt trials.
However, after a closer analysis of a subset of patients in the phase 3 ENGAGE study, Biogen decided it would submit the drug to regulatory agencies for potential approval after all.
The promising data demonstrated that patients who received sufficient exposure to high doses of the drug experienced significant benefits on measures of cognition and function, including memory, orientation and language.
Biogen maintained that failure in the second trial of aducanumab was likely due to the fact that there weren’t a sufficient number of patients receiving enough exposure to the higher dose of the medication.
If aducanumab is approved, Biogen can expect billions of dollars in annual revenues. However, if it is rejected by the FDA, the company will lose one of the most promising growth drivers in its pipeline.