Date: 2016-06-01
Type of information: Granting of a Fast Track status
Product name: aducanumab (BIIB037)
Compound: aducanumab
Therapeutic area: Neurodegenerative diseases
Action mechanism:
- monoclonal antibody. Aducanumab (BIIB037) is a human recombinant monoclonal antibody selected from a population of elderly, healthy donors and cognitively stable patients using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen Idec licensed aducanumab from Neurimmune under a collaborative development and license agreement.
- Aducanumab targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque level.
Company: Biogen (USA - MA)
Disease: Alzheimer’s disease
Latest news:
- • On June 1, 2016, Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was accepted into the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program. PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines for diseases without available treatment or in need of better treatment options. Investigational treatments accepted into PRIME must demonstrate potential for a major therapeutic advantage in areas of unmet medical need. Aducanumab was accepted into PRIME based on results from the Phase 1b placebo-controlled study of aducanumab in patients with prodromal or mild Alzheimer’s disease.
- Through the PRIME program Biogen will have access to enhanced support from EMA, including its advice at key development milestones and the potential for accelerated assessment of a marketing authorisation application (MAA).
- Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
