The U.S. Food and Drug Administration has approved a new lupus drug that was tested at OMRF.
Benlysta, the first new lupus drug approved in 56 years, went through clinical trials led by OMRF physician-scientist Joan Merrill, M.D. The OMRF trials took place in the foundation’s Clinical Pharmacology Research Program, which treats and studies thousands of Oklahomans suffering from lupus and other autoimmune diseases.
“We were one of the many sites around the world that participated in several of the studies of this treatment over the years,” said Merrill, who is also Medical Director for the Lupus Foundation of America. “This approval is great news for patients.”
Lupus is a chronic autoimmune disease affecting an estimated 2 million Americans. The disease causes the body’s immune system to become overactive and instead of attacking foreign invaders, it turns against the body’s own tissues. Lupus affects many parts of the body including joints, skin, kidneys, lungs, heart and the brain.
Before Benlysta’s approval, the last drug approved by the FDA to treat lupus was Plaquenil in 1955. Prior to that, aspirin was approved to treat the disease in 1948.
OMRF’s involvement in the testing of Benlysta began in 2005, when physicians started administering the drug as part of “Phase 2”—or safety—testing to Oklahoma lupus patients interested in receiving the experimental treatments. Testing at OMRF continued for the next six years as the drug progressed to large-scale safety and efficacy trials and a follow-up safety trial.
One stumbling block to the drug was overcome with OMRF’s help. Patients who took part in OMRF’s initial Phase 2 study were given the option of continuing to receive the drug. Information from their monthly treatments over the ensuing half-decade helped provide long-term safety information critical for Benlysta’s approval, Merrill said.
“We’re a long way from a cure or even a comprehensive treatment,” Merrill said. “What this does is give doctors one more tool to help lupus patients live longer and healthier. And we will continue to research novel treatments for the disease to give physicians and patients more and better options.”