Astrazeneca has managed to bag US approval for anifrolumab in systemic lupus erythematosus, despite its mixed data package. The next question is whether the interferon type I inhibitor, now branded Saphnelo, can challenge the leading SLE therapy, Glaxosmithkline’s Benlysta. The latter has disappointed commercially since its launch in 2011 but is expected to finally become a blockbuster this year; sellside consensus compiled by Evaluate Pharma forecasts Benlysta sales of $1.5bn by 2026, versus Saphnelo’s $488m. At least Astra does not have too many other rivals breathing down its neck, a look at the late-stage pipeline shows. Interestingly, Biogen has two shots on goal here, having recently started pivotal development of its second contender, BIIB059. And Roche is also developing Gazyva in lupus nephritis, where Aurinia got approval of Lupkynis earlier this year. Meanwhile, a previous pivotal failure has not put off Immupharma, which is apparently now pushing Lupuzor into a second phase 3, funded by its partner Avion.
|The late-stage systemic lupus erythematosus pipeline|
|Olumiant||Lilly/Incyte||Jak 1 & 2 inhibitor||Brave II ends Oct 2021; Brave I ends May 2022|
|Dapirolizumab||Biogen/UCB||Anti-CD40L MAb||Phoenycs Go ends Feb 2023|
|BIIB059||Biogen||Anti-BDCA2 MAb||Topaz-1 ends Apr 2025; Topaz-2 ends Jun 2025|
|Gazyva||Roche||Anti-CD20 MAb||Allegory ends Nov 2025|
|Lupuzor||Immupharma/Avion Pharmaceuticals||Autophagy immunomodulator||Failed ph3 in Apr 2018, new ph3 planned|
|Source: Evaluate Pharma & clinicaltrials.gov.|