New drug for Lupus approved

By Dr. Ananya Mandal, MDMar 12 2011

A new drug for lupus has won U.S. approval. The drug, Benlysta from Human Genome Sciences Inc., is administered once a month intravenously.

Lupus is a potentially fatal disease that causes the immune system to attack the body’s tissues and organs. Affects mostly women and usually develops between 15 and 44 years. It may lead to arthritis, kidney damage, chest pain, hair loss, fatigue and a rash in shape of a butterfly around the cheeks and nose. The organ damage can be fatal.

Benlysta, generically known as belimumab obtained approval for certain patients with lupus who are already receiving standard therapy. In a study funded by the company, 43 percent of the patients taking a high dose of Benlysta with standard therapies  felt relief and no disease worsening in various organs after a year of treatment.

Some doctors thought the drug to be a breakthrough, but said it does not work for all patients and that more treatments are needed. Other experts described the effects of Benlysta as mild. But the drug holds promise and hope for the estimated 1.5 million people in the U.S. who have some form of the autoimmune disease.

The Lupus Foundation of America hails it as “the first drug ever to be specifically developed to treat lupus.” Till date treatment involved the steroid prednisone, aspirin and Plaquenil, an antimalarial drug

The next set of challenges involves the cost of the drug and complicated reimbursement.