GSK is investing $139m in its biopharmaceutical manufacturing site located in Rockville, Maryland, to expand the production of Benlysta (belimumab).
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Benlysta is indicated for treatment in adult patients with active, auto-antibody positive, systemic lupus erythematosus (SLE) undergoing standard therapy.
The investment will be used to boost the internal capacity of the manufacturing site to improve bulk drug substance production by nearly 50%, to fulfil the growing demand.
The Rockville site is also expected to produce a new subcutaneous form of belimumab that is currently under FDA review.
GSK immunology and rare diseases VP said: “Benlysta is the first medicine specifically developed and approved for SLE in over 50 years.
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By GlobalData“We are so pleased that on the first day of Lupus Awareness Month we are able to announce this expansion in Rockville, increasing our ability to provide this important medicine to patients.”
The company noted that Benlysta, the first medicine specifically developed and approved for SLE in more than 50 years, is a human monoclonal antibody that selectively targets B-lymphocyte stimulator (BLyS), an important factor behind B cells survival.
Benlysta is available as 120mg in a five megalitre (mL), single-use vial and 400mg in a 20mL single-use, which can be administered as intravenous injections.
Lupus is an incurable, chronic, autoimmune disease that can affect any part of the body. It is estimated that nearly five million people are affected with Lupus globally.
In the US alone, 170,000 to 200,000 Americans have SLE, one of the most common and serious forms of Lupus.
GSK claimed that the sales of Benlysta have grown at least 18% annually in the US since 2014.
Last year, the company reported $377m sales of Benlysta in the US.
Image: GlaxoSmithKline head office, London. Photo: courtesy of Ian Wilson/Flickr.
