Investigational Treatment for Guillain-Barré Syndrome Gets Fast Track Status

Guillain Barr
Guillain Barr

The Food and Drug Administration (FDA) has granted Fast Track designation to ANX005 (Annexon Biosciences) for the treatment of Guillain-Barré Syndrome (GBS), an autoimmune disease that can lead to widespread peripheral nerve damage and paralysis.

ANX005 is a C1q inhibitor that is administered intravenously (IV) and works by blocking the activation of the classical complement pathway. C1q is the initiating molecule of the classical complement cascade believed to cause the immune response responsible for GBS, according to the Company. 

The Company plans to investigate the treatment, in combination with intravenous immunoglobulin, in a multicenter, open-label study in patients diagnosed with GBS. ANX005 was previously granted Orphan Drug designation by the FDA for the treatment of GBS.

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“Fast Track designation is a testament to the urgent need for a new therapy to treat patients with GBS, as there are no FDA-approved therapies for this debilitating neurological disease,” said Doug Love, Esq, Annexon’s president and CEO. “Having completed our phase 1b clinical trial in patients with GBS, we look forward to advancing ANX005 into later- stage clinical trials. Our goal is to bring ANX005 to patients with GBS as quickly as possible.”

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