Benlysta marks a landmark for the 19-year-old company as well as for lupus patients: it’s the first drug the FDA has approved from HGS, a company that epitomized the optimistic hype of the biotech bubble a decade ago but had seen numerous drug candidates fail to reach the market since then.
Labinger is optimistic that the drug will be an important treatment for lupus. It works by disrupting the response of B cells, which are white blood cells that create antibodies. Benlysta blocks the action of a protein that causes the cells to proliferate when it is linked to receptors on B cells. In effect, Benlysta dims the immune response, particularly the part that causes autoimmune reactions.
Labinger says the price of Benlysta is in line with that of other monoclonal antibodies, a relatively new class of drugs that are expensive to produce. So far, he said, insurers have shown no hesitation about paying for the drug.
‘A different woman’
For Penny Fletcher, head of the Washington chapter of the Lupus Foundation of America, Benlysta means hope. “I knew Janice when she was just getting into that clinical trial, and she’s a different woman,” Fletcher said, referring to Fitzgibbon. “It has helped her avoid the flares and allowed her to have a more stable health with less pain and fear.
“For the patients it helps, it’s wonderful,” Fletcher adds, “but it’s a significant drug for all patients with lupus” because it may lead to other lupus medications.
In recent decades, many seemingly effective lupus candidate drugs have failed, but the FDA’s licensure of Benlysta has encouraged other companies to stay in the hunt, says Kenneth Kalunian, who directs the Lupus Clinical Trials Consortium branch at the University of California at San Diego. These companies include Genentech, Medimmune, Astra-Zeneca and Eli Lilly.
Nothing is ever simple with lupus, as the HGS trial showed. Lupus symptoms come and go and vary from patient to patient. Since there are few clear tests of the disease’s progression, HGS devised a coding system to measure the drug’s effect on the severity of the participants’ symptoms.