Multinational biotechnology corporation, Biogen and Japanese pharmaceutical enterprise, Eisai, are planning in filing an approval to Food and Drug Administration (FDA) towards a drug for Alzheimer’s that have provided mixed results during clinical trials. Dementia, a common type of Alzheimer’s disease has affected over 50 million individuals worldwide.
Continuous efforts are being put in by researchers to develop and experiment new drugs in trying to reduce, reverse or recover from the manifestation of this incurable illness. Nevertheless, numerous new drugs are being developed by scientists that do not cross the clinical test stage due to their several side effects or failing to be as effective as hoped by their creators. Also certain drugs have provided mixed results during their clinical trials. One of them is aducanumab, a drug developed by researchers associated with Biogen. The company has its headquarters at Cambridge, MA.
The monoclonal antibody aducanumab theoretically should slow down or prevent neurodegeneration. It removes from within the brain the lethal beta-amyloid plaques during the premature stage of Alzheimer’s. Biogen ran two clinical phase III trials but decided to end the tests before its schedule this year in March, following an assessment from an independent team suggesting the futility of the trials meeting their principle endpoint.
The company faced a loss of more than $18 billion following the decision in ending the trials that evaluated the new drug. A recent announcement from Biogen reported their collaboration with Eisai, a Tokyo based pharmaceutical company to submit aducanumab next year for the approval from FDA. Biogen posted a press release where they have explained their decision after analysing their datasets from both clinical trials and consulting their finding accompanied by the FDA.
CEO of Biogen, Michel Vounastos says that their ground-breaking research and steadfast determination have resulted in their announcement towards the drug to fight Alzheimer’s which have affected millions of people worldwide.
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