FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD

FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

ANORO™ ELLIPTA™ is the proposed proprietary name for UMEC/VI, 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.

The FDA Advisory Committee also voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5/25mcg dose for the proposed indication (10 yes, 3 no), and the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD (13 yes, 0 no).

Patrick Vallance, GSK's President of Pharmaceuticals R&D, said: "Today's recommendation is good news and a reflection of our commitment to giving an alternative treatment option for patients living with COPD – a disease that affects millions of Americans. If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GSK's portfolio of medicines to treat respiratory disease. We will continue to work with the FDA as they complete their review."

"We are pleased with the Advisory Committee's support of UMEC/VI," said Rick E Winningham, Chief Executive Officer of Theravance. "This is a transformative year for Theravance and today's positive recommendation brings the second major respiratory medicine in our GSK collaboration closer to approval and becoming an important therapeutic option for COPD patients."

In December 2012, a New Drug Application (NDA) was submitted to the FDA for the use of UMEC/VI administered by the ELLIPTA™ inhaler for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.  UMEC/VI is not proposed for the relief of acute bronchospasm or for the treatment of asthma in any of the regulatory applications.

The FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for UMEC/VI is 18 December 2013.

UMEC/VI is an investigational medicine and is not currently approved anywhere in the world.


Safety Information
Across the four pivotal COPD studies for UMEC/VI, the most frequently reported adverse events across all treatment arms, including placebo, were headache, nasopharyngitis, cough, upper respiratory tract infection, and back pain. COPD exacerbation was the most common serious adverse event reported. In addition, in the four pivotal COPD studies, a small imbalance was observed in cardiac ischemia which was not observed in the long term safety study.

The UMEC/VI clinical development programme involved over 6,000 COPD patients.


About COPD
Chronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterized by obstruction to airflow that interferes with normal breathing. COPD is the third most common cause of death in the US and The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 15 million US adults have COPD and another 12 million are undiagnosed or developing COPD[i].
According to the NHLI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD and in the United States, the most common irritant that causes COPD is cigarette smoke.  Breathing in second hand smoke, air pollution, or chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

Other Respiratory Development Programmes:
Anoro Ellipta is one of several late-stage assets in the GSK respiratory development portfolio. The GSK respiratory development portfolio also includes VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK's investigational medicines fluticasone furoate (FF) monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab).  These investigational medicines are not currently approved anywhere in 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.  For further information please visit www.gsk.com

                                                                                                                  
ANORO™ ELLIPTA™, BREO™ ELLIPTA™ and RELVAR™ ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of ANORO™ ELLIPTA™ and RELVAR™ ELLIPTA™ brand names is not approved by any regulatory authorities.

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 programmes 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 programme.  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.

GSK Global Communications
GlaxoSmithKline
GSK House | 980 Great West Road
Brentford| Middlesex | TW8 9GS UK
T: +44 20 8047 5502

www.gsk.com | Follow us on Twitter | GSK on LinkedIn
GSKvision on YouTube | GSK on Facebook | GSK on Flickr

Suggested Articles

The drug failed a futility analysis in March, but Biogen resurrected it after factoring in data generated after the cutoff for the interim assessment.

The negative top-line data deal a big blow to the prospects of a drug analysts tipped to achieve blockbuster sales if it cleared phase 3.

Intrepida Bio launched with $9.5 million from Sofinnova and Canaan Partners to develop anti-BAG3 antibodies for the treatment of cancer.