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|
|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|
73%, 77% in AQP4+ (N-Momentum)
|72%/73%||$586m||Approved in AQP4 + patients|
|IL-6||Add-on||62% (SakuraSky)||90%/95%||$431m||FDA filing accepted last October|
|Mono||74% in AQP4+ (SakuraStar)||92%/75%|
|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.