Viela Bio’s Uplizna™ Granted FDA Approval As Company’s First Commercial Product

Viela Bio’s Uplizna™ (inebilizumab-cdon), a treatment for adult patients with neuromyelitis optica spectrum disorder (NMOSD), was approved by the U.S. Food & Drug Administration (FDA) late last week. Uplinza is Viela Bio’s first commercial product and yet another milestone achieved for the clinical-stage biotech that spun out of MedImmune/AstraZeneca in 2018.

According to Viela Bio’s website, NMOSD is a rare disease that impacted about 10,000 people as of 2016. NMOSD, according to the National Organization for Rare Disorders (NORD), is a chronic disease of the brain and spinal cord that’s characterized by inflammation of the optic nerve and spinal cord. Those suffering from NMOSD, which can sometimes be mistaken for multiple sclerosis (MS), have attacks that can last days or longer and are followed by a period of remission that can last weeks, months, or even years. Symptoms include eye and spinal cord inflammation, loss of bowel and bladder control, loss of sensation, and even permanent paralysis and blindness. 

Uplizna is a monoclonal antibody therapy that targets and binds to CD19+B cells, which is an antigen on pre-B and mature B cell lymphocytes. B cells are believed to play a critical role in NMOSD. The therapy will be competing against other existing NMOSD products like Alexion’s Soliris and Roche’s Rituxan, which is an off-label treatment for the rare disease. 

Uplizna’s approval comes on the heels of several other positive announcements from the company. 

In late May 2020, Viela Bio raised approximately $169M by offering 3.6M shares of common stock at $47.00 per share. These funds will be deployed to support the commercialization of Uplizna, fund clinical trials for inebilizumab for use in other indications and to progress its other pipeline candidates. The company continues to be a fundraising juggernaut — just 16 months after launch, Viela Bio raised approximately $350M; and only two years in, the company went public, with its early October 2019 IPO generating $172M in gross proceeds.

In mid-May 2020, the company, which is led by CEO Bing Yao, announced positive interim results from its Phase 1b study with VIB7734, its novel anti-ILT7 potential therapy for patients with cutaneous lupus erythematosus (CLE). CLE was selected by Viela Bio to move into this Phase Ib study after it had conducted a Phase Ia clinical study for VIB7734 on a number of other autoimmune diseases, including systemic lupus erythematosus (SLE), , Sjögren’s syndrome, systemic sclerosis, polymyositis, and dermatomyositis.

According to Viela Bio’s website, VIB7734 “…is designed to target and bind to ILT7, a cell surface molecule specific to pDCs, leading to their depletion. The benefits are multifold as this depletion may also decrease other inflammatory cytokines such as TNF-a and IL-6, which are critical to the pathogenesis of a number of autoimmune diseases.”

The positive interim data from VIB7734’s Phase Ib trial showed safety and tolerability comparable to placebo control across all study cohorts, potent pDC depletion, and demonstrated meaningful clinical change in cohorts 2 and 3. 

What’s next for Viela Bio’s efforts to pioneer novel autoimmune and severe inflammatory disease therapies? Pricing Uplizna and getting it out into the market is a critical next step for the company. Advancing its VIB7734 CLE candidate along the pipeline is another important milestone to watch. 

For a BioHealth Capital Region company that’s achieved so much so quickly, the best still might be yet to come. 

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