Once-Daily Trelegy Ellipta Gains Expanded Indication in the US for the Treatment of Patients with COPD

In continuation of my update on fluticasone furoate, umeclidinium and vilanterol

GlaxoSmithKline plc   and Innoviva, Inc.    announced that the US Food and Drug Administration,  has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.

fluticasonefuroate

  umeclidinium

 vilanterol

The new indication is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma.

Dr. Hal Barron, Chief Scientific Officer and President of Research and Development, GSK, said, “Following the initial approval of Trelegy Ellipta in September, we have analysed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with chronic obstructive pulmonary disease. We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly. We will continue to analyse the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients.”

The approval is based on a supplemental New Drug Application (sNDA) supported by data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.

Dr Ted Witek, Senior Vice President and Chief Scientific Officer at Innoviva added: “Up to half of patients with COPD on maintenance therapy will have experienced at least one exacerbation in the past 12 months, so gaining an indication that reflects the role Trelegy Ellipta can play in reducing this risk is important.We welcome this regulatory update which will allow physicians to offer the benefits of once-daily single inhaler triple therapy to appropriate patients with COPD.”1

Trelegy Ellipta was originally approved for use in the US in September 2017 for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo and require additional bronchodilation or who are receiving Breo and Incruse (UMEC). A type II variation to support an expanded label in Europe was submitted to the European Medicines Agency (EMA) in February 2018 and is currently under review.

The boxed warning has also been removed from the Trelegy Ellipta prescribing information, in line with the recent updates to the ICS/LABA class. Labelling changes to ICS/LABA combination medicines were implemented following a review of safety data submitted to the FDA by three companies including GSK and approved on December 20, 2017.

FDA Approves Flonase Sensimist Allergy Relief

In continuation of my update on fluticasone

GSK Consumer Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. Previously available by prescription as Veramyst®, Flonase Sensimist is the latest Rx-to-OTC switch from GSK.

Flonase Sensimist helps block six allergic substances*, providing non-drowsy, 24-hour relief of both nose- and eye-related allergy symptoms like itchy, watery eyes**, nasal congestion, runny nose, itchy nose and sneezing.

“There are roughly 50 million people in the United States who suffer from allergies,2 and, as a category leader, GSK continues to innovate to satisfy the needs of all allergy sufferers,” said Amardeep Kahlon, Director of Marketing. “In the case of Flonase Sensimist, GSK is proud to offer an additional treatment option that not only provides more complete allergy symptom relief1 but also suits specific consumer preferences.”

Additional key features of Flonase Sensimist include:

• Nasal allergy relief indicated for adults and children ages 2 and older**
• Scent-free
• Alcohol-free
• Little or no drip

Flonase Sensimist will be nationally available OTC in early 2017.

About Flonase Sensimist

Flonase Sensimist (fluticasone furoate, 27.5 mcg spray) is an approved over-the-counter treatment for symptoms associated with seasonal and perennial allergic rhinitis including sneezing, runny nose, itchy nose, congestion, and itchy, watery eyes.**

FDA Approves Flonase Sensimist Allergy Relief

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

In continuation of my update on Ellipta (fluticasone furoate)

GlaxoSmithKline plc  announced that the Food and Drug Administration has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)

  The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate above structure) and vilanterol (below structure)  inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations......

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)