The Food and Drug Administration announced its approval of the intravenous drug Benlysta, to treat patients with active auto-antibody-positive lupus, making it the first new drug approved for the debilitating condition since the 1950's.
"The approval of Benlysta follows setbacks suffered by many other companies developing drugs for lupus," according to the NY Times. "Doctors and patient groups have said that having a new drug come to market could encourage other pharmaceutical companies to pursue the disease."
The FDA statement said that prior to Benlysta, that last drugs they approved to treat the disease were Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. The FDA approved aspirin as an additional treatment for Lupus in 1948.
The drug was developed by Human Genome Sciences Inc (HGS). Benlysta will be marketed in the United States in a joint effort with pharmaceutical giant GlaxoSmithKline (GSK).
HGS President and CEO, H. Thomas Watkins, said in a press release, "We and GSK are honored to have the opportunity, with the approval of FDA, to bring Benlysta forward in the United States as the first new drug for systemic lupus in more than 50 years. We expect to have this novel therapy available to physicians and patients within about two weeks."
Moncef Slaoui, Ph.D., Chairman, GSK Research and Development, said in a media statement, “The approval of Benlysta is an important step for appropriate lupus patients. Patients have been waiting for new treatment options to help manage this chronic disease. We look forward to working together with HGS to bring this new medicine to patients in the U.S.”
"Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues, according to the FDA.. The FDA estimates 300,000 to 1.5 million people suffer from the disease. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women."
“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research."
Daily Finance reported "sales of the drug could exceed $3 billion within five years."
"Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines," reported the FDA. Experts tell Daily Finance that "Benlysta is not a miracle drug and was effective in only 35% of the patients tested. African American patients did not appear to respond to treatment with Benlysta."
Benlysta was criticized by FDA reviewers in November, who had "a number of concerns about the drug's efficacy and questioned whether potential benefits outweighed the drug's possible risk of infection, cancer, and suicide, according to a report on MedPage Today.