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(Alliance News) - AstraZeneca PLC on Wednesday said the EU approved its biologic Saphnelo for the treatment of moderate to severe systemic lupus erythematosus, an autoimmune condition.
Biologics are medications made out of components like sugars and proteins. Common examples include vaccines, gene and cellular therapies, and monoclonal antibodies. Saphnelo is a fully human monoclonal antibody.
The Cambridge, England-based pharmaceutical company said that Saphnelo is the first biologic approved for severe systemic lupus erythematosus in the EU with an indication that is not restricted to patients with a high degree of disease activity. Sufferers of the disease can experience long-term organ damage.
The approval by the European Commission is based on results from Saphnelo's clinical development programme that included clinical trials, Astra noted.
These trials showed that more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems compared to a placebo.
AstraZeneca said that it has gained the global rights to Saphnelo through an exclusive licence and collaboration agreement with New Jersey-based biotech company Medarex Inc in 2004.
After its acquisition by New York-based pharmaceutical company Bristol-Myers Squibb in 2009, its option to co-promote the product expired and Astra will pay BMS a low to mid-teens royalty for sales dependent on geography now.
Saphnelo was also approved in the US, Japan and Canada for the treatment of systemic lupus erythematosus and regulatory reviews are ongoing in several other countries, Astra said.
Shares in AstraZeneca were down 0.3% at 8,838.00 pence each on Wednesday morning in London.
By Abby Amoakuh; abbyamoakuh@alliancenews.com
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