Biogen has announced it is bringing back an Alzheimer’s drug it previously deemed a failure and will now apply for regulatory approval from the Food and Drug Administration.
In a press release on October 22, 2019, the Boston-based biotech company reported that its drug aducanumab slowed cognitive decline in patients with early Alzheimer’s disease dementia and MCI due to Alzheimer’s disease. The reversal was based on new analyses of a larger dataset than was available after the trials were discontinued on March 21, 2019.
Biogen halted the trials based on the results of a “futility” analysis conducted by an independent data monitoring committee that concluded the drug was unlikely to yield a positive result.
The most recent review was conducted in consultation with the FDA, including data from patients that received the greatest exposure to a high dose of aducanumab between December 2018 and March 2019, according to STAT.
The review showed aducanumab to be “pharmacologically and clinically active” and that it reduced patients’ clinical decline based on the results of scores on the Clinical Dementia Rating (CDR). The CDR measure is performed by a clinician who interviews and examines the patient and a person who knows the patients well, such as a caregiver.
“While we are all happy that this may ultimately turn into a viable treatment, we should also be cautious until the research community and the FDA has an opportunity to review these data with the company,” said Dr. David Wolk, co-director of the Penn Memory Center and principal investigator for the aducanumab trials at Penn.
Dr. Wolk and his colleagues at the Penn Memory Center explained that they do not have full details of the review and the dataset, so it is difficult for them to know how convincing the data are and the future of this drug.
The results of Biogen’s analysis have not been subject to the peer-review process. The company plans to present the data at the Clinical Trials for Alzheimer’s Disease (CTAD) meeting in December 2019.
Biogen is currently working with the FDA to determine when participants in past studies can resume taking the drug, if they choose to, and the steps necessary for the FDA to review the data describing the drug’s risks and benefits. Biogen plans to file for approval in early 2020.
Dr. Jason Karlawish, co-director of the Penn Memory Center, explained, “These are early days and it remains to be seen how this drug will impact a disease that just 40 years ago was considered rare. As we and our colleagues learn more over the coming months, the Penn Memory Center will update our community.”