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(Alliance News) - AstraZeneca PLC's lupus treatment Saphnelo has been recommended for marketing authorisation in the European Union, the drugmaker said Monday.
Saphnelo is an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus, or SLE.
AstraZeneca said the Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the Saphnelo clinical development programme, including the Tulip phase III trials and the Muse phase II trial.
Executive Vice President of BioPharmaceuticals R&D 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."
Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE, with regulatory reviews ongoing in additional countries.
SLE is a chronic autoimmune disease in which the immune system attacks healthy tissue in the body.
Separately, AstraZeneca announced its Tezspire drug has been approved in the US for severe asthma treatment.
The pharmaceutical behemoth claims Tezspire is the "first and only biologic to consistently and significantly reduce exacerbations in a broad population of severe asthma patients".
The drug, developed with Amgen Inc, can now be used in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma.
US Food & Drug Administration approval was based on results from the Pathfinder clinical trial programme, which showed Tezspire demonstrated "superiority across every primary and key secondary endpoint in patients" compared to placebo.
"Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma," commented Andrew Menzies-Gow, director of the Lung Division at Royal Brompton Hospital, London.
AstraZeneca shares were down 1.5% at 8,388.00 pence early Monday in London.
By Will Paige; willpaige@alliancenews.com
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