Annexon gets FDA fast track status for ANX005 in Guillain-Barré Syndrome

Filed under: Pharma Regulatory News | Tags: , , , , , , ,

Annexon Biosciences has bagged the fast track designation for its C1q inhibitor ANX005 from the US Food and Drug Administration (FDA) for the treatment of Guillain-Barré Syndrome (GBS).

Considered to be a rare, acute, antibody-mediated autoimmune disease, Guillain-Barré Syndrome affects the peripheral nervous system for which there are no approved therapies in the US till date.

Previously, the FDA gave its orphan drug designation for ANX005 for the treatment of Guillain-Barré Syndrome.

Commenting on the regulatory milestone for ANX005, Doug Love – Annexon president and CEO said: “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.

“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.”

The fast track designation from the FDA enables expedition of the development, review and potential approval of investigational drugs designed for the treatment of serious or life-threatening diseases or conditions having an unmet medical need. Products having the fast track status can be eligible for various benefits like more frequent meetings and communications with the US pharma regulator and, if relevant criteria are satisfied, the possibility for accelerated approval, priority review of a new Drug application (NDA) or biologics license application (BLA).

ANX005 is a monoclonal antibody designed for the treatment of patients having autoimmune and neurodegenerative disorders. Formulated for intravenous administration, the monoclonal antibody has been designed to inhibit C1q and the complete classical complement pathway.

Annexon Biosciences had wrapped up a phase 1b clinical trial of ANX005 and is looking to advance the  C1q inhibitor into later-stage clinical trials in Guillain-Barré Syndrome.

Based in California, Annexon Biosciences is a clinical-stage US biopharma company focused on developing a pipeline of therapies for patients having classical complement-mediated disorders of the body, brain, and eye.

Related posts

Leave a Reply

Your email address will not be published. Required fields are marked *