GlaxoSmithKline plc and Theravance Inc. Announce the Submission of Regulatory Application in the European Union for the Investigational Once-Daily LAMA/LABA Combination Medicine, UMEC/VI
January 09, 2013 at 07:29 am EST
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GlaxoSmithKline plc and Theravance Inc. announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD). On 18th December 2012, GSK and
Theravance announced the submission of a regulatory application in the United States (US) for UMEC/VI, for patients with COPD. UMEC/VI is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler. A Marketing Authorisation Application (MAA) for UMEC/VI (55/22mcg and 113/22mcg doses), with the proposed proprietary name ANORO, has been submitted to the European Medicines Agency (EMA) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. The UMEC/VI doses of 55/22mcg and 113/22mcg are specified as the delivered doses (emitted from the inhaler) which are equivalent to the 62.5/25mcg and 125/25mcg pre-dispensed doses (contained inside the inhaler) submitted for approval in the US.
Innoviva, Inc. is a diversified holding company with a portfolio of royalties and other healthcare assets. The Company's royalty portfolio consists of respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI) and ANORO ELLIPTA (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, the Company is entitled to receive royalties from GSK on sales of RELVAR/BREO ELLIPTA. The Company's products include GIAPREZA and XERAVA. GIAPREZA (angiotensin II) injection is approved by the United States Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAV (eravacycline) for injection is approved by the United States FDA and Singapore Health Sciences Authority (HSA) as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI).
GlaxoSmithKline plc and Theravance Inc. Announce the Submission of Regulatory Application in the European Union for the Investigational Once-Daily LAMA/LABA Combination Medicine, UMEC/VI
INNOVIVA, INC. 
