GSK, Theravance To File New Drug Application in Japan For Relvar Ellipta COPD Therapy

GSK, Theravance To File New Drug Application in Japan For Relvar Ellipta COPD Therapy

On September 24, 2015, GlaxoSmithKline and Theravance announced their intention to file a Japanese New Drug Application (sJNDA) for Relvar® Ellipta® (fluticasone furoate “FF”/vilanterol “VI” or “FF/VI”) for the treatment of chronic obstructive pulmonary disease (COPD). The application to the Japanese regulatory authority is scheduled for the first quarter of 2016 and is the result of an additional global phase III efficacy and safety evaluation.

Chronic obstructive pulmonary disease is characterized by blocked airflow through the lungs. In the US, the disease affects more than 3 million individuals per year and men and women are affected almost equally. A number of risk factors have been pointed out to cause COPD including genetic predisposition, tobacco smoking, dust, air pollution, chemicals, fumes, and other diseases like HIV/AIDS, pneumonia, asthma, and tuberculosis. Symptoms of patients with COPD may include cough, rapid breathing, frequent respiratory infections, shortness of breath, fatigue, and exercise intolerance. COPD is a disease that usually worsens over time and, as it progresses it, can result in serious symptoms such as leg swelling, bulging neck veins, and high pressure in the lung arteries. Additionally, patients with COPD may experience a sudden worsening of symptoms, called an acute exacerbation. These exacerbations often result from bacterial/viral infections, exposure to environmental pollutants as tobacco smoke, change in temperature, and improper utilization of drugs.

There is no known cure for COPD, but the disease can be managed by lifestyle changes, oxygen therapy, and oral or inhaled medications, which may control symptoms and minimize progression of the damage caused by the disease. With respect to medications, regulations often vary from one country to another. For example, currently FF/VI is not prescribed for treatment of COPD in Japan, but approved in 2013 by the Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of asthma in patients above 15 years old. Because the collected efficacy data within the FF/VI phase III clinical trial on Japanese patients with COPD were insufficient, the present study for Relvar Ellipta aims to collect further data from a group of patients treated with combination FF/V if compared with its component VI.

The clinical trial included 1,620 patients from 11 countries with moderate to severe COPD were included, 370 of which were from Japan. The participants were required to have at least one COPD exacerbation in their disease history that needed to be treated based on systemic/oral corticosteroids and/or antibiotics and/or hospitalization during the last 12 months. The patients were also required to have current symptoms of COPD including combination of breathlessness, cough, sputum, and nighttime awakenings requiring treatment with the medication albuterol [salbutamol]) for a minimum of 5 of the 7 days immediately preceding their participation.

Over the course of 12 weeks, the patients received once-a-day FF/VI 100/25 microgram or VI 25 microgram in the dry powder inhaler (DPI) Ellipta®. The results illustrated that when compared to VI 25 microgram, the patients who received the 100/25 microgram FF/VI showed significant improvement in lung function. The frequently reported side-effects were mainly based on nasopharyngitis (6% VI, 6% FF/VI), COPD exacerbation (4% VI, 2% FF/VI) and headache (2% VI, 4% FF/VI). Other rare side-effects like pneumonia were also cited by patients in each treatment group (below 1% VI, below 1% FF/VI).

In conclusion, the FF/VI drug also known as Breo Ellipta in some other markets such as the US appears to be very promising as a treatment for COPD with minimal side effects. The details of these clinical trials will be the subject of a future presentations and/or publications. More information about the study could be found at www.clinicaltrials.gov (NCT02105974).

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