Anoro ElliptaTreatment for Chronic Obstructive Pulmonary Disease
Update: Anoro Ellipta Now FDA Approved - December 18, 2013
FDA Advisory Committee to Review Anoro Ellipta NDA
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 09/10/13 -- Theravance,Inc. (NASDAQ: THRX) today announced that NASDAQ halted trading of Theravance common stock this morning, September 10, 2013. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) meets today to discuss the new molecular entity New Drug Application (NDA) 203975 for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO™ ELLIPTA™), sponsored by Glaxo Group (d/b/a GSK) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. 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. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance's key programs include: RELVAR™ ELLIPTA™ or BREO™ ELLIPTA™ (FF/VI), ANORO™ ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance's web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of the brand names ANORO™ and RELVAR™ has not yet been approved by any regulatory authority.
Michael W. Aguiar
Senior Vice President and Chief Financial Officer
Source: Theravance, Inc.
Posted: September 2013
- FDA Approves Anoro Ellipta to Treat Chronic Obstructive Pulmonary Disease - December 18, 2013
- FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD - September 10, 2013
- Theravance Announces FDA Advisory Committee to Review Anoro Ellipta (UMEC/VI) for COPD - August 2, 2013
- GSK and Theravance Announce FDA Acceptance of New Drug Application Submission in the US for Anoro Ellipta for COPD - February 19, 2013