FDA Begins Review of Biologics License Application for Neuromyelitis Optica Spectrum Disorder Drug

According to a press release from Maryland-based Viela Bio, the US Food and Drug Administration (FDA) recently agreed to review the Company’s Biologics License Application for its neuromyelitis optica spectrum disorder drug candidate, inebilizumab.

About Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica spectrum disorder (NMOSD), sometimes colloquially referred to as Devic disease, is a highly rare brain and spine disorder frequently characterized by the inflammation of the spine and optic nerves.

When the optic nerves are inflamed, patients feel a pain coming from inside the eye that is often accompanied by a rapid loss in vision acuity (sharpness). Inflammation of the spinal cord (myelitis), however, has far more broad-reaching effects. Inflammation of the spine can cause communication problems in the central and secondary nervous systems, impeding or blocking neural impulses from traveling beyond a certain point in the spine like a damaged section of highway. Motor and sensory dysfunction of varying degrees is common. Patients may feel pain in their limbs or spine, and may have difficulty controlling voluntary muscle movement, particularly in the lower limbs.

Because the early symptoms of NMOSD are similar to those experienced in the early stages of multiple sclerosis, it can be difficult for physicians to initially confirm a diagnosis. Studies have shown that most cases of NMOSD are not chronic but relapsing-remitting, with patients sometimes going years between attacks.

The condition is autoimmune, caused by a malfunctioning immune system that mistakenly targets healthy tissues and organs as though they were harmful foreign pathogens. Cases seem to be non-hereditary, with up to 95% of recorded patients having no known relatives who share the condition. Personal or family histories of autoimmunity, however, were present in 50% of the same group.

Currently, no long-term treatment for suppressing NMOSD exists. Acute attacks are most commonly treated with high-concentration corticosteroids to manage pain and inflammation.

About Inebilizumab

Inebilizumab is an experimental “anti-CD19 monoclonal antibody.” It targets a protein called CD19, which is found on the surface of many immune B cells. When inebilizumab binds to CD19 in these immune cells, they become ineffective. In theory, by reducing the number of active B cells in NMOSD patients, physicians can limit the overactive immune response that causes attacks.

Recently, the FDA agreed to review the Biologics License Application (BLA) for inebilizumab. The BLA is like the New Drug Application (NDA) but for biologics (a drug produced from natural sources, like a living organism), meaning approval is all that stands in the way between inebilizumab and NMOSD patients.

Viela Bio submitted the BLA on the basis of exciting clinical trial data that suggested inebilizumab could significantly lower the risk of NMOSD attack in patients when compared to placebo. After 28 weeks of the study, participants treated with inebilizumab were 77% less likely to experience NMOSD attacks than their peers in the placebo arm.

The final ruling from the FDA is likely to come in the next few months.

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