FDA approves GSK's albiglutide

FDA approved Tanzeum albiglutide from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat Type II diabetes as monotherapy or as add-on therapy. GSK plans to launch Tanzeum in the U.S. next quarter, but declined to comment on pricing. The drug is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist comprised of two copies of modified human GLP-1 fused in series to human albumin. Tanzeum has a black box warning on the risk of thyroid C cell tumors and was approved with a REMS comprising a communication plan. GSK is required to conduct a postapproval cardiovascular outcomes trial; the pharma declined to comment on a timeline for starting the trial. ...