Trelegy Ellipta is the first once-daily single inhaler triple therapy to
be approved in
The first European launch is expected to take place before the end of the year.
For the EU Summary of Product Characteristics please visit: http://ec.europa.eu/health/documents/community-register/index_en.htm. Prior to this being posted online, a copy may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Enquiries" section at the end of this document.
COPD is a progressive lung disease that is thought to affect around 384 million people worldwide.1
For people living with COPD, the inability to breathe normally can consume their daily lives and make simple activities, like walking up stairs, an everyday struggle.
Long-term exposure to inhaled irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.2
Every person with COPD is different, with different needs, different challenges and different goals. Understanding this and providing support to help meet these needs is the foundation of GSK's work.
About the Clinical Development Programme Supporting the European Marketing Authorisation
The European Marketing Authorisation for FF/UMEC/VI is based on efficacy and safety data from the FF/UMEC/VI development programme, as well as data from studies with the components either alone, or in combination. The results of the phase 3 FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) study were published in 2017 (Lipson DA et al. Am J Resp Crit Care Med 2017).
Other Regulatory Activity
Full US prescribing information, including BOXED WARNING and Medication Guide are available at: https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/trelegy/pi/home.html.
Regulatory applications for once-daily single inhaler triple therapy FF/UMEC/VI have been submitted and are undergoing assessment in a number of other countries.
Important Safety Information for FF/UMEC/VI in the EU
The following Important Safety Information is based on a summary of the Summary of Product Characteristics for Trelegy Ellipta (FF/UMEC/VI). Please consult the full Summary of Product Characteristics for all the safety information.
FF/UMEC/VI is contraindicated in patients with hypersensitivity to either fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI) or any of the excipients.
FF/UMEC/VI should not be used in patients with asthma since it has not been studied in this patient population. FF/UMEC/VI is not indicated for the treatment of acute episodes of bronchospasm. In the event of deterioration of COPD during treatment with FF/UMEC/VI, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Systemic steroid effects may occur with any inhaled corticosteroid (ICS), particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Patients with moderate to severe hepatic impairment receiving FF/UMEC/VI should be monitored for systemic corticosteroid-related adverse reactions.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
FF/UMEC/VI should be used with caution in patients with convulsive disorders or thyrotoxicosis, in patients who are unusually responsive to beta2-adrenergic agonists and in patients with pulmonary tuberculosis or in patients with chronic or untreated infection.
Consistent with its antimuscarinic activity, FF/UMEC/VI should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving ICS. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among ICS products.
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. No clinically relevant effects of hypokalaemia were observed in clinical studies with FF/UMEC/VI at the recommended therapeutic dose. Caution should be exercised when FF/UMEC/VI is used with other medicinal products that also have the potential to cause hypokalaemia.
Beta2-adrenergic agonists may produce transient hyperglycemia in some patients. No clinically relevant effects on plasma glucose were observed in clinical studies with FF/UMEC/VI at the recommended therapeutic dose. Upon initiation of treatment with FF/UMEC/VI, plasma glucose should be monitored more closely in diabetic patients.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take FF/UMEC/VI.
The most frequently reported adverse reactions with FF/UMEC/VI were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%). Other common adverse reactions (reported with a frequency of ≥1/100 to < 1/10) include: pneumonia, pharyngitis, rhinitis, influenza, cough, arthralgia and back pain.
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Trade marks are owned by or licensed to the GSK group of companies.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2016.
This press release contains certain "forward-looking" statements as that
term is defined in the Private Securities Litigation Reform Act of 1995
regarding, among other things, statements relating to goals, plans,
objectives and future events, including the development, regulatory and
commercial plans for closed triple combination therapy and the potential
benefits and mechanisms of action of closed triple combination therapy.
1. Global Initiative for Chronic Obstructive Lung Disease Global
Initiative for Chronic Obstructive Lung Disease. 2017. Pocket guide to
COPD diagnosis, management, and prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
2. Diagnosis of COPD.
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