The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca’s Saphnelo (anifrolumab) in the European Union (EU) to treat adult patients with systemic lupus erythematosus (SLE).
A fully human monoclonal antibody, Saphnelo targets subunit 1 of the type one interferon (type 1 IFN) receptor, blocking the type 1 IFN’s activity.
It has been recommended as an additional therapy to treat moderate to SLE in adult patients, who are receiving standard therapy.
The CHMP’s decision is based on the data obtained from the Saphnelo clinical development programme that included Phase III TULIP trials and the Phase II MUSE trial.
In the clinical trials, Saphnelo showed overall disease activity reduction across organ systems, along with reduction in oral corticosteroid (OCS) use, compared to placebo.
The adverse reactions observed in the three clinical trials include bronchitis, herpes zoster, upper respiratory tract infection, and infusion-related reactions.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.”
If approved by the European regulatory authorities, Saphnelo will be the first new SLE treatment in Europe over a decade.
Recently, the monoclonal antibody has been approved in Japan, Canada, and the US, with regulatory reviews underway in other countries.