Benlysta belimumab regulatory update
The European Commission approved an MAA from GlaxoSmithKline for Benlysta belimumab as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), with a high degree of disease activity, despite standard therapy. The B-lymphocyte stimulator ( BLyS)-specific inhibitor received a positive opinion from EMA's CHMP in May. GSK and Human Genome Sciences said that Germany will be the first major European market to launch Benlysta in the next few weeks (see BioCentury, May 23).
The European label for Benlysta does not recommend its use to treat severe active lupus nephritis or severe active CNS lupus - populations not included in Phase III trials of the compound. The label also says that caution should be exercised if the drug in used in combination with other biologics or cyclophosphamide, combinations which were not studied. ...