GlaxoSmithKline Says Partner HGSI Files Benlysta For US Approval

10th Jun 2010 12:45

By Sten Stovall Of DOW JONES NEWSWIRES LONDON (Dow Jones)--GlaxoSmithKline Plc (GSK) Thursday said partner Human Genome Sciences Inc. (HGSI) has applied for U.S. regulatory approval for their jointly-developed drug Benlysta, potentially the first new treatment in decades for the hard-to-treat autoimmune disease lupus. Benlysta, or belimumab, is not approved or licensed anywhere in the world but the U.K. drug maker and its Rockville, Md.-based partner have high hopes for the treatment. Their application to the FDA for a Biologics License Application follows a filing earlier this month to Europe's drug regulator for marketing approval there. Analysts say Benlysta could be on the market late this year or in early 2011 and project the drug's annual sales to eventually exceed $1 billion a year. With lupus, the immune system attacks a patient's own tissue, causing inflammation, pain and other symptoms. The disease tends to flare up and then recede into periods of remission. The complexity of the disease has so far frustrated drug companies. Physicians now prescribe anti-inflammatory drugs, corticosteroids, and other medicines for lupus, but Benlysta is expected to be the first therapy developed specifically for the disease to reach market. Benlysta, which is administered intravenously, showed that it can reduce disease activity in two Phase III clinical studies, known as BLISS-52 and BLISS-76. Clinical research also suggests that the drug may make patients less prone to flare-ups, which can cause serious organ damage. "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," said H. Thomas Watkins, President and Chief Executive Officer of Human Genome Sciences, in a statement earlier this month. Benlysta is being developed by GlaxoSmithKline and Human Genome Sciences under a co-development and commercialization agreement entered into in 2006. -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; [email protected] (END) Dow Jones Newswires June 10, 2010 07:45 ET (11:45 GMT)