Biogen and Eisai have announced that the European Medicines Agency (EMA) accepted to review the marketing authorisation application (MAA) for aducanumab, an investigational antibody therapy for Alzheimer鈥檚 disease.聽
If granted approval, aducanumab, a human monoclonal antibody, will become the first treatment to reduce the clinical decline in patients with Alzheimer鈥檚 disease.
Under a co-development and licensing deal, Biogen licensed aducanumab from Neurimmune.聽
Biogen and Eisai collaborated on the development and commercialisation of aducanumab worldwide from October 2017.
Biogen CEO Michel Vounatsos said: 鈥淎lzheimer鈥檚 disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease.
鈥淲e are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency鈥檚 review of this application.鈥�
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By GlobalDataAlzheimer鈥檚 disease is a progressive neurological condition that impairs thinking, memory and independence, leading to premature death.聽
Mild cognitive impairment due to the disease is an early stage of the disease when symptoms start to be more visible.
Clinical data from patients with mild cognitive impairment due to Alzheimer鈥檚 disease and mild Alzheimer鈥檚 disease showed treatment with aducanumab resulted in the removal of amyloid-beta and better outcomes.聽
In August, the US Food and Drug Administration (FDA) accepted the biologics license application (BLA) for aducanumab. The application, granted priority review, has a Prescription Drug User Fee Act (PDUFA) action date on 7 March.
During the same month,聽Biogen inked a binding agreement with Denali Therapeutics聽to jointly develop and commercialise therapeutics for Parkinson鈥檚 disease.
