GSK

GlaxoSmithKline (GSK) has obtained Japanese approval for its Encruse Ellipta (umeclidinium).

The Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval for the drug to provide relief from various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (COPD).

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Encruse is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator that can improve airflow in and out of the lungs. It is a 62.5mcg strength inhalation powder that can be delivered in the Ellipta inhaler.

GSK global respiratory franchise senior vice-president and head Darrell Baker said: “Encruse is our first LAMA monotherapy and the second treatment from our new COPD portfolio to be approved in Japan within the last year.

“Approval was based on a review of ten Phase III clinical trials, which comprised 4,000 COPD patients treated with umeclidinium or a placebo.”

“The Ellipta inhaler has been positively received by physicians in Japan and today’s approval reflects our goal of providing a range of respiratory medicines in a consistent inhaler that enables physicians to meet the specific needs of individual patients.”

Approval was based on a review of ten Phase III clinical trials, which comprised 4,000 COPD patients treated with umeclidinium or a placebo.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to GSK, 983 patients received the approved dose of umeclidinium 62.5mcg once-daily in these studies. The company plans to launch the product by the end of 2015 in Japan.

GSK also received MHLW approval for Duac Combination Gel (clindamycin 1%-benzoyl peroxide 3%) to treat acne vulgaris.

In addition, the company obtained approval for pneumococcal conjugate paediatric vaccine Synflorix to treat invasive infectious diseases and pneumonia caused by pneumococcus (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).

Developed by GSK, Synflorix was commercialised by Japan Vaccine, a joint venture of GSK and Daiichi Sankyo.

Image: Chest X-ray demonstrating severe COPD. Photo: courtesy of James Heilman, MD.