The First Triple Therapy for COPD Patients Trelegy Ellipta Gets FDA Approval

According to a company press release, officials with the Food and Drug Administration (FDA) have approved Trelegy Ellipta, a once-daily, triple therapy, fluticasone furoate/umeclidinum/vilanterol (FF/UMEC/VI) for the long-term maintenance treatment of patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

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It is the first product to have been approved in the United States that has a combination of three active molecules in a single-dose inhaler, and to be taken once every day for the treatment of COPD including chronic bronchitis and emphysema. The press announcement came from GlaxoSmithKline (GSK) and Innoviva Inc. saying that the drugs will be available to patients soon.

The triple therapy manufactured by GSK is approved for COPD patients on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction. It is also approved for patients that are already taking umeclidinum and a fixed-dose combination of vilanterol and fluticasone furoate. GSK and Innoviva noted that it was not indicated for treatment of asthma or the relief of acute bronchospasm.

Trelegy Ellipta consists of a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2 adrenergic agonist (LABA) to be delivered orally, once-daily, through GSK’s Ellipta dry powder inhaler. The strength which has been approved is FF/UMEC/VI 100/62.5/25 mcg.

GSK estimates that approximately one quarter of patients diagnosed with COPD already use the three drugs in Trelegy Ellipta individually to treat COPD and hopes that this product will prove to be an attractive and simpler alternative regimen for such patients.

A positive opinion recommending the marketing authorization for the medication as a maintenance treatment in appropriate adults with COPD in its moderate to severe stages was issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CMPH) on the 15^th of September, 2017.

The CEO of Innoviva Inc., Mike Aguair, said, “This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta. Trelegy Ellipta is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”

Eric Dube, SVP & Head, GSK Global Franchise, said, “COPD is a progressive disease that can worsen over time and represents a significant burden to patients and healthcare systems. The approval of Trelegy Ellipta, and the addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for the GSK that builds on our long term heritage in this area.”

There has been submission of regulatory applications which are being assessed in a number of other countries including Canada, Australia and the European Union. Trelegy Ellipta will be available very soon in the United States; it is however not licensed as a single inhaler triple therapy anywhere else apart from the United States.

What is COPD?

COPD is a chronic condition in which there is slow, progressive obstruction of airflow into or out of the lungs. It is mainly characterized by shortness of breath. It includes emphysema and chronic bronchitis which can also occur at the same time. It is believed to affect close to 384 million people in the whole world and about 30 million people in the United States alone.

It is a progressive disease which means that it gets worse over time. Life can become very difficult when you are living with COPD due to the worsening of your symptoms and lack of ability to breathe normally. This can devastate your life making simple day to day tasks such as walking up a flight of stairs to your house a daunting task. It ends up affecting your life quality because there are some activities that you may not be able to carry out over time.

Exposure to lung irritants for a long period of time damages your lungs and your airways and may cause COPD. Air pollution, presence of dust in your environment, cigarette smoke as well as second-hand smoking, and chemical fumes can all be contributors to COPD. Most of the people diagnosed with COPD are at least 40 years old when they symptoms start to show.

Symptoms may include having a chronic cough, production of a lot more mucus than usual, having a blue color on your nail beds and lips and wheezing among many others. Seek medical attention should you experience any of these to be checked for COPD.

Important Safety Information for Trelegy Ellipta

The following is based on the highlights section of the United States Prescribing Information for Trelegy Ellipta:

• It is contraindicated in patients with severe hypersensitivity to milk proteins or any of its ingredients.
  
  
• Its safety and efficacy in patients with asthma has not been established. It is not indicated for the treatment of asthma.
  
  
• Because of risk of overdose, it should not be used in combination with other medicines containing LABA.
  
  
• It should not be initiated in patients experiencing episodes of acutely deteriorating COPD. Do not use to treat acute symptoms.
  
  
• Candida albicans infection of the pharynx and the mouth has occurred in patients treated with fluticasone furoate which is one of the three components contained in Trelegy Ellipta. Patients should be monitored periodically and advised to rinse their mouth with water without swallowing after inhalation to reduce risk.
  
  
• Patients that use corticosteroids are at risk of potentially worsening of infections that they have. For example existing tuberculosis and bacterial, fungal or viral infections and should be used with caution in patients that have such infections.
  
  
• Increased risk of pneumonia in COPD patients taking Trelegy Ellipta. Patients taking it should be monitored for signs and symptoms of pneumonia.
  
  
• Trelegy Ellipta should be used with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
  
  
• Hypercortism and adrenal suppression may occur with very high dosages. They may also occur at the regular dosage with susceptible individuals. Appropriate therapy should be considered if such changes occur.

The most common adverse reactions reported for Trelegy Ellipta (incidences less than or equal to 1 percent) are; dysgeusia, cough, headache, gastroenteritis, back pains, diarrhea and oropharyngeal pain.