16th Dec 2025 09:53
(Alliance News) - AstraZeneca PLC on Tuesday said its drug Saphnelo, or anifrolumab, has been approved in the European Union as a new pre-filled pen for systemic lupus erythematosus.
The Cambridge, England-based pharmaceutical company said the approval is for subcutaneous self-administration of the drug, on top of standard therapy.
Systemic lupus erythematosus is an autoimmune condition that affects 3.4 million people globally. It primarily affects women and can cause pain, rashes, fatigue, swelling in joints and fevers.
In Europe, people with SLE have a two to three times increased risk of death compared to the overall population.
The approval by the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use and was based on positive results from the phase three Tulip-SC trial.
In the trial, subcutaneous administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to the placebo in participants with moderate to severe, active, autoantibody-positive SLE.
"We are committed to improving lupus care and since launch, Saphnelo IV infusion has transformed outcomes for tens of thousands of people living with systemic lupus erythematosus," said Ruud Dobber, executive vice president of the Biopharmaceuticals unit at AstraZeneca.
"With approximately 70% of SLE patients on biologics in Europe using a subcutaneous self-administration option, today's approval means we can now offer the clinically meaningful benefits of Saphnelo while expanding patient choice in how and where they receive treatment."
Subcutaneous administration of Saphnelo is under regulatory review in several other countries, including the US and Japan.
Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in over 70 countries including the US, EU and Japan.
AstraZeneca bought the global rights to Saphnelo through a licence and collaboration agreement with Medarex Inc in 2004.
The option for Medarex to co-promote the product expired when it was bought by Bristol-Myers Squibb Co in 2009.
Under the agreement, AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.
Shares in AstraZeneca were down 0.2% at 13,582.00 pence on Tuesday morning in London.
By Michael Hennessey, Alliance News reporter
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