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news.Theravance, announced that on March 19, 2015, the US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss the supplemental New Drug Application (NDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO ELLIPTA), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older.
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BREO ELLIPTA is a fixed dose combination of the inhaled corticosteroid, fluticasone furoate (FF) and the long-acting beta2 agonist (LABA), vilanterol (VI), administered using the ELLIPTA inhaler.
The Prescription Drug User Fee Act (PDUFA) goal date is April 30, 2015. FF/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.
Theravance is focused on maximizing the potential value of the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA and ANORO ELLIPTA, with the intention of providing capital returns to stockholders.
Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement with GSK, Theravance is eligible to receive the associated royalty revenues from RELVAR/BREO ELLIPTA (fluticasone furoate/vilanterol, "FF/VI"), ANORO ELLIPTA (umeclidinium bromide/vilanterol, "UMEC/VI") and if approved and commercialized, VI monotherapy.
Theravance is also entitled to a 15% economic interest in any future payments made by GSK under agreements entered into prior to the spin-off of Theravance Biopharma, and since assigned to Theravance Respiratory Company, LLC, relating to the combination of UMEC/VI/FF and the Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program, as monotherapy and in combination with other therapeutically active components, such as an inhaled corticosteroid, and any other product or combination of products that may be discovered and developed in the future under these agreements with GSK (other than RELVAR/BREO ELLIPTA, ANORO ELLIPTA and VI monotherapy).