Partner HGSI Files Benlysta For US Approval: GSK

GlaxoSmithKlineFirst potentially new treatment in decades for the hard-to-treat autoimmune disease lupus might be on the shelves soon as GlaxoSmithKline Plc (GSK) on Thursday said partner Human Genome Sciences Inc. (HGSI) has applied for U. S. regulatory approval for their jointly-developed drug Benlysta.

As of now no where in the world Benlysta, or belimumab, is approved or licensed but there are high hopes for the treatment by the U. K. drug maker and its Rockville, Md.-based partner. An application earlier this month was submitted to the FDA for a Biologics License to Europe's drug regulator for marketing approval there.

H. Thomas Watkins, President and Chief Executive Officer of Human Genome Sciences, said, "Based on the results of our pivotal Phase 3 studies, we believe Benlysta has the potential to become the first new approved drug for systemic lupus in more than 50 years."

The drug can be expected in the market late this year or in early 2011.