AstraZeneca PLC (LSE:AZN)'s Saphnelo (anifrolumab) therapy has been recommended for marketing authorisation in the European Union (EU) as treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE).
If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade, the pharmaceuticals company said in a statement.
SLE is an autoimmune disease that can affect any organ and people often experience inadequate disease control, long-term organ damage and poor quality of life.
The recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency was based on trial results where Saphnelo was shown to reduce overall disease activity in SLE patients.
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Ian Bruce, professor of rheumatology at the University of Manchester and steering committee chair for the Saphnelo SLE clinical development programme, said: "Systemic lupus erythematosus is a complex and heterogeneous disease that can have a debilitating impact on a person's quality of life.
“The anifrolumab clinical programme has provided compelling evidence that this medicine has the potential to be an important new option for patients."
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, added: "Saphnelo is a ground-breaking first-in-class medicine and offers physicians and patients a new way of treating systemic lupus erythematosus by targeting the type I interferon receptor, which is known to play a central role in lupus disease pathophysiology.
“This positive recommendation from the CHMP brings us one step closer to providing a much-needed new treatment option to improve outcomes for patients in Europe."
Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE, and regulatory reviews are ongoing in additional countries.
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