The U.S. Food and Drug Administration (FDA) has announced the approval of an oral medicine called Lupkynis (voclosporin) for a kidney disease caused by lupus, an autoimmune disorder.
The kidney disease caused by lupus is called lupus nephritis, which could lead to kidney failure, heart complications, and even death if left untreated.
Lupkynis is given along with immunosuppressant drugs to treat lupus nephritis.
The drug, developed by Aurinia Pharmaceuticals, a Canadian biopharmaceutical company, costs $3,950 for a “wallet” of 60 capsules, which would last for 10 days.
Nearly 1.5 million Americans are affected by lupus, according to the Lupus Foundation of America. There are relatively few new treatment options for the condition.
Anti-inflammation drugs, steroids, immunosuppressant drugs, and antimalarial drugs like hydroxychloroquine have been advised to manage the symptoms of lupus. In 2011, the FDA approved a specific drug for lupus, called Benlysta (belimumab), developed by GlaxoSmithKline. And now, the FDA approved Lupkynis.
Brad Rovin of Ohio State University’s Wexler Medical Center said in a statement from Aurinia, “For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic.”
The Lupkynis approval “allows us to treat patients safely and more effectively with a rapid-acting therapy which requires far less steroids, something our patients will appreciate,” he added.
In Phase 3 clinical trials, the participants who received the drug for a year achieved a complete kidney response and certain measures of kidney health faster than those who were given a placebo.
However, some participants reported side effects such as headache, diarrhea, high blood pressure, and decreased kidney filtration rates.
Lupkynis comes with a boxed warning for an increased risk of developing malignancies and serious infections. The article appeared on Healthcare Dive, an online news outlet.
