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...

HGS’ lupus drug Benlysta fails secondary trial goal

Human Genome Sciences (NASDAQ: HGSI) has released an updated look at its experimental lupus drug, noting that the closely watched Benlysta failed to achieve a secondary endpoint on a statistically significant response after 76 weeks of therapy. The primary endpoint was a significant response after a year of therapy, though, a key objective that has already been hit in the pivotal Phase III. A total of 38.5 percent of all lupus patients responded to the high dose of Benlysta after 76 weeks,...