AstraZeneca Plc (AZN), said on Monday that its anifrolumab, sold under the brand name saphnelo, a prescription medicine used to treat the patients with moderate to severe systemic lupus erythematosus or SLE, has been recommended for the approval in the European Union or EU, by the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA.
The drug has been recommended as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive SLE, despite receiving a standard therapy, the company said in a statement. SLE is a disease in which the immune system attacks body's healthy tissues.
If the drug is approved by the EU authorities, then Saphnelo is expected to be the first new treatment for SLE in the region in over a decade.
However, the adverse reactions that reported more frequently in patients who received saphnelo in the three clinical trials are upper respiratory tract infection, bronchitis, infusion-related reactions, and herpes zoster.
Saphnelo was recently approved in the US, Japan, and Canada for the treatment of SLE, and regulatory reviews are under process in additional countries.
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