Unless you have been in a cave today, you shold know that Human Genome Sciences (HGS) and its partner GSK did receive word from the FDA as expected that their new lupus drug, Benlysta (belimumab), has been approved. This is the first new lupus drug in 56 years - yes - 56 years. The injectable drug, which will be marketed by Human Genome Sciences and GlaxoSmithKline, is forecast to generate at least $2 billion in annual sales thanks to its $35,000 price tag.
“Benlysta will remain the only marketed US biologic for lupus for at least the next three years,” Datamonitor analyst Joe Dixon writes in a note. “However, there is competition looming with several Phase III agents in development, including UCB’s epratuzumab.
"It's a very exciting time in lupus," says Richard Furie, a rheumatologist at the North Shore-Long Island Jewish Health System in New York, who has conducted clinical trials of belimumab. "There's an awful lot of activity right now." Several companies have similar drugs in the pipeline, and are likely to be spurred on by belimumab's success, notes Furie. Before 2009, when data from two large, successful clinical trials of belimumab were released, no drug developed for lupus had ever made it through a phase III clinical trial.
Belimumab's success has lessened that stigma, Human Genome Science's vice-president David Stump told investors yesterday: "We have shown with Benlysta that the barriers that have existed for all of these years for drug development in lupus can be overcome."
Posted by Bruce Lehr March 10th 2011.