HGS files for FDA approval of breakthrough lupus drug

Human Genome Sciences (HGSI) and its partner GlaxoSmithKline took another big step forward on their new lupus drug Benlysta, filing for FDA approval on a therapy that is widely expected to generate blockbuster revenue once it hits the market.

In two large Phase III trials researchers produced clearly positive data on the drug's ability to reduce disease activity as well as lower the frequency of the flare-ups that plague lupus patients. Patients today are prescribed corticosteroids and other drugs to help moderate the symptoms of the disease, but if approved Benlysta would become the first therapy designed specifically to treat the condition.

"Based on the results of our pivotal Phase III studies, we believe Benlysta has the potential to become the first new approved drug for systemic lupus in more than 50 years," said HGS CEO Tom Watkins (photo). The drug has helped revive HGS and spurred its share price, allowing the company to raise fresh funds to fuel future growth. Analysts give the therapy high marks, and an approval could come as early as this year.

- read the HGS release
- here's the story from the Wall Street Journal