GlaxoSmithKline plc (GSK) and Theravance, Inc. announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine fluticasone furoate “FF”/vilanterol “VI” (FF/VI) for patients with chronic obstructive pulmonary disease (COPD) and a regulatory application for asthma in the European Union.
European Submission
A Marketing Authorisation Application (MAA) for FF/VI, with the proposed brand name Relvarโข, administered by a new dry powder inhaler called Elliptaโข, has been submitted to the European Medicines Agency (EMA) for the following indications:
Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.
COPD (100/25mcg): The symptomatic treatment of patients with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history.
US Submission
A New Drug Application (NDA) for FF/VI, with the proposed brand name Breoโข, administered by the Elliptaโข inhaler, has been submitted to the US Food and Drug Administration (FDA), for the following indication:
COPD (100/25mcg): The long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations.
For asthma, GSK and Theravance are reviewing the strategy for a future US filing.
FF/VI is one of several late-stage assets in the GSK respiratory development portfolio, which also includes the investigational LAMA/LABA combination umeclidinium bromide/vilanterol (UMEC/VI),VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK’s investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab).
Relvarโข or Breoโข (FF/VI and previously referred to as Relovairโข) is an investigational medicine and is not currently approved anywhere in the world. Relovairโข, Relvarโข, Breoโข and Elliptaโข are trademarks of the GlaxoSmithKline group of companies. The use of these brand names is not approved by regulatory authorities around the world.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
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: Relvarโข/Breoโข, LAMA/LABA (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist (PฮผMA) 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.
