On Thursday, GlaxoSmithKline Plc. said that collaborator Human Genome Sciences Inc. has filed for U. S. regulatory sanction for their jointly developed medicine Benlysta, probably the first new cure in ages for the hard-to-cure autoimmune sickness, lupus.
Benlysta, or belimumab, is not backed up or approved anywhere in the globe, but the U. K. drug manufacturer and its Rockville, Md.-based associate have pinned high expectations for the treatment.
Their application to the FDA for a Biologics License Application comes after a filing prior this month to Europe's drug controller for promoting sanction there.
Analysts say that Benlysta might reach the markets late this year, or in early 2011 and estimate the drug's yearly sales to ultimately surpass $1 billion a year.
The immune system of a person suffering from lupus assaults the victim's own tissue, resulting in inflammation, ache and other signs. The ailment is likely to burst out and then retreat into phases of remission.
The intricacy of the disease has to date irritated drug firms. Doctors now recommend anti-inflammatory drugs, corticosteroids, and other medicines for lupus, but Benlysta is anticipated to be the first therapy developed particularly for the disease to hit the markets.
Benlysta is administered intravenously and has proved to diminish the disease’s movement in two Phase III medical studies, called BLISS-52 and BLISS-76.