NOTICIAS DIARIAS

FDA Approves COPD Medication – Trelegy Ellipta

Anaesthesiology

Trelegy Ellipta is a combination of fluticasone furoate, umeclidinium, and vilanterol.  FDA has approved this once-daily, single inhaler triple therapy for patients with COPD. According to a company news release, the approved indication includes patients with chronic bronchitis and emphysema. The patients who are on a fixed-dose combination of fluticasone furoate and vilanterol for air flow obstruction.

The fluticasone furoate is an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The combination inhaler contains 10 µg fluticasone, 62.5 µg umeclidinium, and 25µg vilanterol.

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," Mike Aguiar stated.

The patients using inhaler (incidence ≥ 1%) reported most frequent adverse events namely headache, back pain, dysgeusia, diarrhoea, cough, oropharyngeal pain, and gastroenteritis.

As the safety and efficacy parameters has not been established in asthma patients, this inhaler is not intended for use in this population. The combination inhaler carries the same risks as those of its individual components. It should not be used in combination with other medications containing long-acting β2-adrenergic agonists because there is a risk for overdose.

Patients taking systemic corticosteroids have an increased risk for potentially worsening infections. In addition, patient is prone to develop serious or fatal chickenpox or measles.In patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, the inhaler should be cautiously used.

Trelegy Ellipta is a combination of fluticasone furoate, umeclidinium, and vilanterol.  FDA has approved this once-daily, single inhaler triple therapy for patients with COPD. This approval represents a significant therapeutic convenience for those appropriate patients. The combination inhaler is recommended for human use by the European Medicines Agency's Committee for Medicinal Products. It is not currently licensed anywhere outside the United States.