Biogen, a biopharmaceutical company in the US, have recently announced that they will be applying for a biologics license for a new drug developed to treat early stage Alzheimer’s. The clinical trial for the drug was previously halted at its third phase in March, however analysis of a larger dataset has shown that the treatment can slow the progression of cognitive decline.
The drug on trial, Aducanumab, is a derivative of a specific protein discovered in the brains of healthy elderly people, as well as in cognitively impaired brains with a slow pattern of decline. This biologic drug is being used to target another protein called amyloid beta, which, in Alzheimer’s disease, is found in the brain clumped together in abnormal quantities. By preventing the formation of these abnormal amyloid beta plaques, Aducanumab could help to preserve the cognitive functions that are lost as a result of Alzheimer’s.
Anton Porsteinsson, director of the University of Rochester’s Alzheimer’s programme in New York state and lead investigator in the study, said it provided new hope for families. “There is tremendous unmet need and the Alzheimer’s disease community has been waiting for this moment,” he added.
Biogen have expressed their intention to submit a Biologics License Application to the US Food and Drug Administration (FDA) in early 2020. This announcement has been a surprising turn of events as earlier on in March this year, they had decided to halt the third phase of their clinical trials. This was due to evaluation of early data predicting that the primary outcome of the study would not be completed by the end of the trial.
According to the previous data on approval times for such license applications, the approval process could take up to 2 years until physicians will be able to prescribe the drug for patients. Biogen have also stated that they ‘will continue dialogue with regulatory authorities in international markets including Europe and Japan’.
In response to the announcement, Hilary Evans, Chief Executive at Alzheimer’s Research UK, said: “The FDA will now assess the new data and its strengths and limitations before deciding about whether aducanumab should be made widely available in the US.
Should Aducanumab be given approval by the FDA, Biogen have stated that they will offer the drug to previous patients who are still eligible from the third phase of the clinical trial. This would provide relief to many of the patients who had been benefitting from the therapy when the company had announced to halt development of the drug.
“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s,” said Michel Vounatsos, Chief Executive Officer at Biogen.
Although unable to cure the disease, there is use for the drug in preventing the manifestation of symptoms such as memory loss and preserving patients’ independence for longer.
Dr Cath Mummery, Head of Dementia Research Trials, UCL, said: " Even if we just slowed the course of the disease in total, by say, five years, we would halve the number of people that have Alzheimer's in this country [the UK] at any one time.”