What is it about?

Review the therapeutic potential of different types of biologics for the treatment of neurological diseases. Preclinical and clinical studies that investigate the efficacy and safety of biologics in the treatment of neurological diseases, namely Alzheimer’s disease, amyotrophic lateral sclerosis, Parkinson disease, multiple sclerosis, and stroke, were reviewed. Moreover, the authors describe the key challenges in the development of therapeutically safe and effective biologics for the treatment of neurological diseases.

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Why is it important?

Treating neurological diseases has been recognized for several decades as a challenging task in the drug discovery venue. Part of this is due to the complexity of CNS which has been traditionally viewed as an immune-privileged site, a BBB that prevents free diffusion of cells and molecules, and a limited knowledge in the role of a glymphatic system in drug disposition.


Several biologics have shown promise in the treatment of neurological diseases. However, the complexity of the CNS, as well as a limited understanding of disease progression, and restricted access of biologics to the CNS has limited successful development. Therefore, more research needs to be conducted to overcome these hurdles before developing effective and safe biologics for neurological diseases. The emergence of new technologies for the design, production and delivery of biologics will accelerate translating biologics to the clinic.

Donna Volpe
U.S. Food and Drug Administration

Read the Original

This page is a summary of: The development of biological therapies for neurological diseases: moving on from previous failures, Expert Opinion on Drug Discovery, February 2018, Taylor & Francis,
DOI: 10.1080/17460441.2018.1437142.
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