Michel Vounatos, CEO, Biogen, said he was ‘incredibly humbled’ to share that the therapy had been granted accelerated approval.
The monoclonal antibody is the first new treatment approved for Alzheimer’s since 2003. Unlike currently available therapies – which only treat symptoms of the disease – Aduhelm is the first therapy to target and affect the underlying disease process of Alzheimer’s.
Alzheimer’s research: a 99.6% failure rate
Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks.
The diseases affects an estimated 6.2 million Americans (and an estimated 35 million people worldwide), and the impact is only expected to worsen with an aging population.
And yet despite the pressing need, developing treatments has proved to be a difficult task. The last time a drug for Alzheimer’s was approved by the FDA was in 2003. Since then, however, there have been at least 100 drug development programs discontinued: demonstrating the complexities of Alzheimer’s research. In fact, during the period 2002-2012, the 413 Alzheimer’s disease trials recorded had a 99.6% failure rate.
In clinical trials, Aduhelm reduced amyloid beta plaques by 59-71% at 18 months of treatment, according to Biogen.
Aduhelm focuses on tackling the accumulation of amyloid beta plaques in the brain: with such plaques a defining pathology of Alzheimer’s disease.
Research at Swiss biotech Neurimmune, in collaboration with the University of Zurich, led to the identification of protective anti-amyloid antibodies in healthy elderly people and patients with slowly progressing dementia. Biogen licensed aducanumab from Neurimmune in 2007 under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.