The FDA has approved one of GlaxoSmithKline's formulations for rheumatoid arthritis. | Courtesy of Shutterstock
+ Regulatory
Amanda Rupp | Oct 2, 2016

FDA approves GlaxoSmithKline treatment for rheumatoid arthritis

The U.S. Food and Drug Administration (FDA) recently approved a Biologics License Application (BLA) for a GlaxoSmithKline plc (GSK) sirukumab that is designed to treat rheumatoid arthritis.

Janssen Biotech Inc. submitted the application for approval of sirukumab’s subcutaneous formulation, a human anti-interleukin (IL)-6 monoclonal antibody. It is specifically designed for adults who have moderate or severe rheumatoid arthritis.

Qualifying patients must have demonstrated a failure to respond to -- or an intolerance of -- disease-modifying antirheumatic drugs (DMARDs).

This formulation has an affinity to selectively bind with IL-6 cytokine, a natural protein that is found in autoimmune conditions.

The new treatment is just one of approximately 40 assets that GSK’s research and development team showed to investors in November of last year. Six core areas comprise the company's research focus in its immuno-inflammation portfolio, which features vaccines, oncology, respiratory, infectious and rare diseases.

“We are pleased with the progress being made to seek regulatory approval of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis,” Paul-Peter Tak, GSK’s chief immunology officer and senior vice president of research and development, said. “If approved, sirukumab would provide these patients with another treatment option. This U.S. submission follows one made for Europe earlier this month, and we look forward to the outcome of the regulatory authority reviews.”

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