As expected, Viela Bio Inc. won FDA clearance for the humanized anti-CD19 monoclonal antibody Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a rare neuroinflammatory disease. Approval of the drug as first-line monotherapy was based on efficacy and safety data from the pivotal N-MOmentum trial, which knocked down the relapse risk by 77%.
The company said it expects to launch Uplizna this month. Pricing has not yet been disclosed.
Also known as Devic disease, NMOSD is a chronic disorder of the brain and spinal cord characterized by inflammation of the optic nerve and myelitis. Though once regarded as monophasic, it’s now recognized that most patients experience repeated attacks separated by periods of remission, according to the National Organization for Rare Disorders. The interval between attacks may be weeks, months or years.
Early stage NMOSD in years past was often misdiagnosed as multiple sclerosis (MS), since it attacks the myelin sheath that makes neuronal high-speed communication possible. The distinction between MS and NMOSD became clearer with the discovery that the majority of NMOSD patients exhibit antibodies to a water channel, aquaporin 4 (AQP4), expressed on the astrocytes that support the myelin sheath, itself made up of oligodendrocytes. Greater than 95% of patients with NMOSD report no relatives with the disease, but there is a strong association with a personal or family history of autoimmunity, present in 50% of cases.
Data from N-MOmentum were discussed at the American Academy of Neurology meeting in early May. The same event featured results from the phase III trial called Prevent with Soliris (eculizumab, Alexion Pharmaceuticals Inc.), and data from Basel, Switzerland-based Roche Holding AG on late-stage satralizumab for relapse prevention. Soliris was first approved in March 2007 for paroxysmal nocturnal hemoglobinuria; NMOSD was added to the label in late June 2019.
Gaithersburg, Md.-based Viela has submitted IND applications to begin human studies of Uplizna in myasthenia gravis and IgG4-related disease and plans to start phase III pivotal and phase IIb trials, respectively, in midyear 2020. The firm kicked off a phase II trial in 2019 for kidney transplant desensitization but, due to the COVID-19 pandemic, the company has voluntarily paused enrollment of new patients in that study.
Wainwright analyst Raghuram Selvaraju, estimating a second half 2020 launch for Uplizna in a May 14 report, predicted sales totaling $42.4 million for the year and 2021 revenue reaching $118 million. The Vela “sales force of roughly 100 reps has already been fully hired; thus, the company should be able to effect a timely and rapid launch, in our view,” he wrote, adding that “multiple virtual promotional and marketing strategies have been formulated to support the [Uplizna] launch despite COVID-19-related social distancing restrictions, which are slated to substantively limit face-to-face sales activities.” Plans to launch right away despite the pandemic “constitutes a very positive sign, as is management commentary indicating keen interest in the [Uplizna] product profile from physicians in the target prescriber population,” he said. Viela signed a deal in October 2019 with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, to develop and commercialize the drug in nine Asia regions for NMOSD as well as other potential indications.
Prescribing information for Uplizna includes a warning for infusion reactions, potential depletion of certain proteins (hypogammaglobulinemia), and potential for increased risk of infection, including progressive multifocal leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis.
In late May, Viela raised about $169 million by selling 3.6 million shares of its common stock for $47 each. Shares (NASDAQ:VIE) closed June 12 at $46.83, down $4.62.