HGS’s hep C drug Zalbin hits an FDA hurdle

Human Genome Sciences' hopes of gaining quick FDA approval of its hepatitis C drug Zalbin appear to be foundering. The Rockville, MD-based developer released a statement this morning that the FDA had raised concerns about the risk/benefit of albinterferon alfa-2b dosed every two weeks, leading it to conclude that an approval is "unlikely." HGS's partner on the drug, Novartis, yanked the European application for the drug--dosed at 900 micrograms--back in April, saying it needed to produce a...

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 cancer drug fails another mid-stage trial

Human Genome Sciences (HGSI) says that a combination of Velcade and its experimental cancer drug mapatumumab (HGS-ETR1) flunked a mid-stage trial for multiple myeloma, with the data failing to demonstrate an improvement over Velcade alone. "The results showed no difference in disease response or progression-free survival for the combination that included mapatumumab vs. the control group receiving bortezomib alone, and showed that mapatumumab was well tolerated in this study," HGS said in a...

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,...