FDA to review lixisenatide
FDA accepted for review an NDA from Sanofi (Euronext:SAN; NYSE:SNY) for lixisenatide to treat adults with Type II diabetes. The pharma submitted the NDA in December, but the PDUFA date is not disclosed. Earlier this month, the European Commission approved an MAA for the glucagon-like peptide-1 receptor ( GLP-1R) agonist, which Sanofi plans to launch as Lyxumia late this quarter. The pharma has global commercialization rights to lixisenatide under a 2003 deal with Zealand Pharma A/S (CSE:ZEAL), which was up DKK1 to DKK81 on Tuesday.
FDA also accepted for review an NDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Anoro Ellipta umeclidinium bromide/vilanterol for bronchodilator maintenance treatment of airflow obstruction in patients with chronic obstruction pulmonary disease (COPD). The PDUFA date is Dec. 18. An MAA for the fixed-dose inhaled dry powder formulation of a long-acting muscarinic antagonist (LAMA) and a long-acting adrenergic receptor beta 2 agonist (LABA), which is administered with the Ellipta inhaler, is also under review by EMA. GSK and Theravance (NASDAQ:THRX), which was up $0.10 to $22.23 on Tuesday, are partnered under a 2002 deal to develop compounds to treat asthma and COPD. ...