A niche market beckons for Viela’s Uplizna

Astrazeneca’s spinout Viela Bio gained its first approval yesterday: that of inebilizumab, trademarked Uplizna, for the rare autoimmune condition neuromyelitis optica spectrum disorder. However, extensive off-label use of rituximab could be a barrier to adoption. Both rituximab and Uplizna are B-cell-depleting therapies, and payers could require patients to take rituximab, including biosimilars, before more expensive treatments like Uplizna are considered. If that is the case, and a patient were to fail on a relatively cheap B-cell depleter, physicians might choose to move to a different mechanism of action – such as Alexion’s Soliris, an anti-C5 MAb approved last year – instead of using a second, more expensive B-cell-depleting agent. Other projects are vying for the US market, which comprises 4,000-8,000 patients; Roche’s satralizumab has been filed in the indication, and ultomiris, a follow on to Soliris, is in phase III.

Neuromyelitis optica landscape

Project Company Target Setting Reduction in attack risk (study) Treatment/ placebo adverse event rate 2026e NMO sales US status
Soliris Alexion


Mainly add-on 94% in AQP4+(Prevent) 92%/91% $488m Approved in AQP4 + patients

Roche (also biosimilars)

CD20 Mono or combo 70-89% (various) 90%/90% - Used off-label
Uplizna Viela Bio CD19 Mono

73%, 77% in AQP4+ (N-Momentum)

72%/73% $586m Approved in AQP4 + patients

Roche/ Chugai

IL-6 Add-on 62% (SakuraSky) 90%/95% $431m FDA filing accepted last October
Mono 74% in AQP4+ (SakuraStar) 92%/75%
Ultomiris Alexion


Add-on ? AQP4+(NCT04201262) ? $264m Phase III primary completion Nov 2021
AQP4 = aquaporin 4 antibody, a key biomarker for disease found in around 80% of NMOSD patients.
Source: Company releases, Stifel & EvaluatePharma. 

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