FDA approves new lupus drug
Treatment likely to cost $30,000 a year in U.S.
WASHINGTON – The Food and Drug Administration on Wednesday approved Benlysta as the first new drug treatment for lupus in 56 years, offering possible relief from painful symptoms to victims of the sometimes fatal autoimmune disease.
The decision was widely expected after an FDA advisory panel voted 13-2 in November to recommend approval of the drug and sets the stage for likely blockbuster sales for the drug’s developer, Human Genome Sciences Inc.
“It’s an historic day. It really does open a door,” said Sandra Raymond, president of the Lupus Foundation of America. “Not that Benlysta is a miracle drug. It’s not. I think the lupus community is sanguine about that. But they know that there are other companies coming behind” Human Genome.
The drug is likely to cost at least $30,000 per year in the U.S., according to Avik Roy, who follows the company for Monness, Crespi, Hardt & Co. It has potential global sales of $5 billion, he said.
In an autoimmune disease such as lupus, the body’s immune system can’t tell the difference between healthy substances and harmful ones and attacks its own tissues and organs.
Symptoms vary widely, making the disease hard to diagnose and treat. Symptoms can include joint pain, fatigue, fever, stiffness, mouth sores, hair loss and rashes. The disease can attack the kidney, lungs and other internal organs, leading to death.
One of Benlysta’s benefits is that patients can use less prednisone, a steroid also used to control symptoms, said Cynthia Aranow, co-director of autoimmune diseases and clinical research at the Feinstein Institute for Medical Research in Manhasset, N.Y.
Prednisone has numerous troubling side effects including osteoporosis, diabetes and high blood pressure, Aranow said.