EMA publishes first lupus guidelines

EMA released its first set of guidelines on Wednesday for the development of therapeutics in the EU for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). According to the Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), which in 2011 became the first drug to be approved in over 50 years in the EU to treat SLE, had a primary composite endpoint of SLE Responder Index (SRI) at 52 weeks. SRI was a novel endpoint devised by the company and includes no worsening in physician global assessment (PGA) score and a four or greater point reduction in a score measuring 16 clinical events and eight laboratory results. EMA's guidelines said the endpoint is an accepted, validated endpoint. ...