First New Lupus Drug in 50 Years Wins FDA Approval

L.L. Woodard
Thu Mar 10, 7:53 pm ET

In what is being hailed as a hallmark in health care, the U.S. Food and Drug Administration has approved Benlysta, a medication designed for treatment of lupus erythematosus. Not only is Benlysta the first new drug for lupus in more than 50 years to reach the market, but it is the first drug derived from the study of genes (genomics), reports The Wall Street Journal.

Lupus is an autoimmune disorder that affects nearly 1.5 million Americans, with women of all races nine times more likely than men to develop the disease. African Americans, Hispanics, Asians and Native Americans have a higher disease incidence than Caucasians.

The development of Benlysta has been years in the making and is the product of a joint effort between Human Genome Sciences, Inc. and GlaxoSmithKline. To date, Benlysta is the first drug to be approved by the FDA that has been developed through the 20-year-old Human Genome Sciences company.

The FDA press announcement of Benlysta's approval states that the medication is approved for the treatment of active systemic lupus erythematosus. Two clinical studies involving more than 1,500 participants provided the FDA with evidence of the drug's safety and efficacy.

The positive results of the drug's use to reduce flare-ups and to allow lupus sufferers to decreases their steroid medications suggested, but did not firmly establish these results. Study results demonstrated that Benlysta does not work for the most severe forms of lupus and was only effective in 35 percent of the North American participants, according to the AP.

A troubling fact is that the medication failed to show positive results for African American study participants. The FDA has requested and Human Genome Sciences has agreed to conduct a new study to ascertain treatment and safety outcome potentials for African Americans and those of African descent.

Benlysta is administered intravenously. Many study participants experienced reactions from their IV infusions; the FDA states that pre-treatment with antihistamines "should be considered." The most common side effects of the drug include nausea, fever and diarrhea, but there was also an increased number of deaths and serious infections in study participants who received Benlysta over the placebo drug.

Persons on Benlysta therapy should not receive live vaccines.

A medication guide must be provided to patients who are considering the use of Benlysta for treatment of their lupus so they can understand the risks involved.

This new drug may give hope to 200,000 currently diagnosed lupus sufferers and may also spur new developments in the treatment of the disease.

Smack dab in the middle of the baby boomer generation, L.L. Woodard is a proud resident of "The Red Man" state. With what he hopes is an everyman's view of life's concerns both in his state and throughout the nation, Woodard presents facts and opinions based on common-sense solutions.

Article: HERE