Pharmaceutical company Biogen has announced that it will pursue US Food and Drug Administration (FDA) approval for its Alzheimer's drug.
Biogen and its Japanese partner Eisai made the announcement on Tuesday that they will seek FDA approval for aducanumab, an experimental drug for early Alzheimer's disease treatment.
Previously, phase 3 clinical trials of aducanumab were discontinued in March as results of a futility analysis revealed that they were unlikely to meet their primary goals at completion. However, Biogen stated that a new analysis, which included more patients, showed a significant reduction in clinical decline in one trial.
Biogen claimed that results of the study indicated that those who received aducanumab experienced significant benefits on measures of cognition and function, including memory, orientation and language.
According to the company, it will make an FDA filing in early 2020 and will continue to discuss the drug with regulatory authorities in Europe and Japan. The pharmaceutical firm will also offer eligible patients previously enrolled in the phase 3 studies access to the treatment.
Biogen chief executive officer (CEO) Michel Vounatsos said: "This is the result of groundbreaking research and is a testament to Biogen's steadfast determination to follow the science and do the right thing for patients."
"We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer's disease and the potential implication of these results for similar approaches targeting amyloid beta," he added.
According to the "amyloid hypothesis", the primary cause of the Alzheimer's disease is the accumulation of beta-amyloid in the brain and this hypothesis has been the basis of Alzheimer's research for over 20 years.
Biogen's decision to pursue FDA approval for aducanumab was applauded by the Alzheimer's Association.
Maria Carrillo, chief science officer at the Alzheimer's Association, said "The Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose."
