2020-03-05| Trials & Approvals

GSK’s Trelegy Ellipta, an Advanced Treatment for Asthma & COPD Submitted for EU Approval

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

GlaxoSmithKline (GSK), a science-led global healthcare company, has endeavored in advanced management of asthma and chronic obstructive pulmonary disease (COPD) for over 50 years. Last week, GSK and its U.S. partner Innoviva announced the acceptance of a regulatory submission of Trelegy Ellipta asthma inhaler for adults by the European Medicines Agency (EMA). Submissions for Trelegy’s regulatory approval for asthma treatment were previously accepted by the US Food and Drug Administration (FDA) in December 2019 and Japan’s Ministry of Health, Labor and Welfare in November 2019.

Asthma is a chronic lung disease that causes inflaming and narrowing of airways. Currently, there is no single inhaled triple therapy available in Europe and around 358 million people worldwide are suffering from it. Trelegy Ellipta is a potentially convenient drug due to its function as a once-daily, single inhaler triple therapy. In addition, at least 30% of asthma patients continue to be plagued by the asthmatic symptoms when treated with the currently approved therapy, a combination of an inhaled corticosteroid and a long-acting β-2 agonist (ICS/LABA, or Relvar/Breo Ellipta). With the high demands for revolutionary asthma treatments, Trelegy Ellipta has contributed $668 million in revenue globally in 2019 and is expected to touch $1.7 billion by 2023.


CAPTAIN: Clinical Study of Trelegy Ellipta

The critical Phase II clinical study CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single Inhaler) is weighted as the bulk of the regulatory submission to EMA. The triple therapy is a combination of three compounds: fluticasone furoate (an inhaled corticosteroid), umeclidinium (along-acting muscarinic antagonist), and vilanterol (a long-acting β-2-adrenergic agonist), administered through GSK’s Ellipta dry powder inhaler. CAPTAIN was a randomized, double-blinded, active-controlled, six-arm parallel-group, global multicenter study evaluating the efficacy of Trelegy Ellipta (FF/UMEC/VI: 100/62.5/25mcg, 200/62.5/25mcg, 100/31.25/25mcg, and 200/31.25/25mcg) compared to FF/VI (100/25mcg and 200/25mcg). CAPTAIN was conducted in 2436 adult asthma patients across 15 countries who react poorly to Relvar/Breo Ellipta treatment to demonstrate that Trelegy Ellipta shows a statistically significant improvement in lung function over the previous, inadequately controlled treatments.


Warnings & Precautions

According to the U.S. Prescribing Information for Trelegy Ellipta, there is important safety information provided for healthcare givers, patients and groups of interest to remain aware of the individual medical conditions and assess potential side-effects while considering administrating Trelegy Ellipta to their patients.

In terms of acute symptoms, Trelegy Ellipta is not indicative of relief for acute bronchospasm, patients experiencing episodes of acutely deteriorating COPD and increased risks of pneumonia in patients with COPD. In terms of patients with decreasing bone mineral density, hyperplasia, bladder neck obstruction, it is suggested to consider referral to an ophthalmologist and urologist, because worsening of narrow-angle glaucoma and urinary retention may occur. Other patients with convulsive disorders, diabetes mellitus, thyrotoxicosis, and ketoacidosis should also use Trelegy Ellipta with caution.

Special recognition to Trelegy Ellipta ingredient, including LABA, fluticasone furoate and β-adrenergic agonist, is required. LABA monotherapy can increase the risk of serious asthma-related events. Trelegy Ellipta should not be used in combination with other medicines containing LABA to avoid an overdose. Candida albicans infection of the mouth and pharynx can occur in patients treated with fluticasone furoate (an inhaled corticosteroid) and therefore, it is advised to rinse the mouth with water without swallowing after inhalation to help reduce the risk. In addition, hypercorticism and adrenal suppression may take place with a very high dosage or even at the regular dosage of Trelegy Ellipta to susceptible individuals. Patients with cardiovascular disorders should be cautious due to β-adrenergic stimulation while being administered Trelegy Ellipta.

Lastly, the most common side-effects reported include upper respiratory tract infection, oral candidiasis, headache, back pain, diarrhea, gastroenteritis, cough, dysphonia, pneumonia, arthralgia, sinusitis, influenza, pharyngitis, dysgeusia, rhinitis, constipation, urinary tract infection, bronchitis, oropharyngeal pain.




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