GSK Expands Maryland Plant to Manufacture SLE Therapy Benlysta for a Booming U.S. Market

Ines Martins, PhD avatar

by Ines Martins, PhD |

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Booming sales of Benlysta (belimumab) to treat adults with active, autoantibody-positive systemic lupus erythematosus (SLE) have led British pharmaceutical giant GlaxoSmithKline to invest $139 million in its manufacturing plant in Rockville, Maryland.

The facility, which will expand the company’s bulk substance production by nearly 50 percent, will produce a new subcutaneous, self-injectable form of Benlysta that now awaits approval by the U.S. Food and Drug Administration (FDA).

Benlysta is an antibody engineered to inhibit a protein called B-lymphocyte stimulator (BLyS), which is involved in the balance and control of immune cells and in mechanisms underlying SLE. Benlysta received U.S. and European approval in 2011 as an intravenous, one-hour infusion to be taken every 28 days.

Clinical trials have shown that Benlysta improved SLE symptoms and reduced organ-specific manifestations of the disease, such as lupus nephritis, which affects the kidneys. Prolonged Benlysta treatment also improves quality of life and eases fatigue in patients with active, autoantibody-positive SLE, according to seven-year clinical trial results released by GSK last year.

Since 2014, U.S. sales of Benlysta have grown by 18 percent annually. Last September, GSK submitted to the FDA a Biologics License Application and a Marketing Authorization Application to the European Medicines Agency for subcutaneous Benlysta as add-on therapy in adults with active autoantibody-positive SLE with a high degree of disease activity despite standard therapy.

Both regulatory agencies will likely rule on the applications later this year. The subcutaneous formulation of Benlysta is currently not approved for use anywhere in the world.

“Benlysta is the first medicine specifically developed and approved for SLE in over 50 years,” Sheri Mullen, GSK’s vice-president for immunology and rare diseases, said in a press release. “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.”

May 2017 is Lupus Awareness Month.