AstraZeneca spinoff Viela Bio scored its first FDA nod. Can it face down heavyweight rivals?

FDA Building
The FDA has approved Viela Bio's first medicine, Uplizna, two years after the company spun off from AstraZeneca. (FDA)

Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplizna following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. 

Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch.

Doctors could prescribe Roche’s Rituxan or its biosimilars off label before trying Uplizna, Evaluate Vantage reports, or payers could require them to try the cheaper options first. Uplizna is a B cell depleter like Rituxan, so if those older options don’t work, docs might go another route and try Alexion’s Soliris rather than move on to Uplizna, Vantage said.

And that's not all: Looking forward, Roche has filed its candidate satralizumab in the same indication, and Alexion’s Ultomiris—a follow-up to the aging Soliris—is in phase 3 testing. 

NMOSD is a rare but severe neuroinflammatory autoimmune disease that can be fatal. Patients can experience vision loss, paralysis, bladder dysfunction, nerve pain and respiratory failure, among other complications. There are an estimated 10,000 patients with NMOSD in the U.S., and Viela says around 80% test positive for anti-AQP4 antibodies.

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Viela launched in 2018 as AstraZeneca worked to refocus on oncology. The drug giant offloaded several programs in inflammatory and autoimmune diseases, and six of them ended up at Viela. The company raised $250 million in a series A in February 2018 and executed a $150 million IPO last year. 

Uplizna is Viela’s first approved medicine, and the company expects to roll it out this month. The drug previously scored FDA breakthrough therapy and orphan drug designations. 

In a phase 3 clinical trial, 89% of patients who were anti-AQP4 antibody positive were relapse-free during the six-month period after Uplizna treatment. That compares with 58% of placebo patients. Treatment with Uplizna was also associated with fewer NMOSD-related hospitalizations. 

Editor's note: This story was updated with the correct spelling of Viela's new medicine, Uplizna.