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FDA fast tracks novel treatment for Guillain-Barré syndrome
The FDA has granted fast track designation to ANX005, a novel treatment for Guillain-Barré syndrome, Annexon Biosciences announced.
Guillain-Barré syndrome (GBS) is a rare, acute autoimmune disease in which the immune system mistakenly attacks part of its peripheral nervous system. There is no known cure for the disease, which is usually triggered by an infection. GBS affects approximately 0.8 to 1.9 per 100,000 people in North America and Europe annually, according to Annexon. In recent years, outbreaks have been associated with Zika virus infection.
According to Annexon, ANX005 is a clinical stage investigational monoclonal antibody intended to treat patients with autoimmune and neurodegenerative disorders and formulated for IV administration. A phase 1b clinical trial of ANX005 has been completed and the company is planning for later stage clinical trials in GBS.
Before receiving fast track designation, ANX005 was granted orphan drug designation from the FDA for the treatment of GBS, a designation reserved for drugs or biological products created to treat a rare disease or condition.
“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,” Doug Love, Esq, president and chief executive officer of Annexon Biosciences, said in a news release. “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.” – by Caitlyn Stulpin
Disclosure: Love is an employee of Annexon Biosciences.