GSK’s Trelegy medicines for asthma and chronic obstructive pulmonary disease (COPD) have been linked to adverse reactions in 11.36 percent of asthma patients and 38.61 percent of COPD patients in a post-marketing surveillance (PMS) study in Korea, the Korean drug regulator said.
On April 9, the Ministry of Food and Drug Safety announced an order to change the license content for the inhalation drug combining umeclidinium, fluticasone, and vilanterol, to reflect the results of a post-marketing survey. The affected products are GSK’s Trelegy Ellipta and Trelegy 200 Ellipta inhalers.
On March 25, the MFDS' Drug Approval Division sent a notice to the drugmaker and conducted an opinion survey. The deadline for submitting an opinion was April 8, and the prior notification period is from April 9 to 24. The scheduled date for the change order is May 19.
According to the proposed changes to the license, the adverse event rate was 11.36 percent (15 patients, 15 events) in a six-year study of 132 patients with asthma. Of these, no serious adverse drug reactions and no unexpected adverse drug reactions for which causality could not be excluded were reported.
A six-year postmarketing study of 606 patients with COPD reported a 38.61 percent (234 patients, 368 events) adverse event rate. Of these, 0.17 percent (1 patient, 2 events) were serious adverse reactions for which causality could not be excluded and 0.66 percent (4 patients, 4 events) were unexpected adverse reactions.
Serious adverse events included exacerbation of chronic obstructive pulmonary disease and dyspnea. Unexpected adverse events included throat tightness, oral pain, and esophageal candidiasis.
Trelegy Ellipta and Trelegy 200 Ellipta inhalers are a triple combination treatment of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) in a metered-dose nebulized inhaler that is administered once daily on the same timeline.
Trelegy Ellipta was approved in May 2018 and received health insurance coverage for COPD maintenance therapy in June 2021, followed by coverage expansion to asthma in March 2024. Trelegy 200 Ellipta inhalation was approved for maintenance therapy for adult asthma patients in September 2022 and has been reimbursed since March 2024.
Trelegy Ellipta and Trelegy 200 Ellipta inhalers are reimbursed for the maintenance treatment of adult patients with asthma who have experienced at least one severe exacerbation within a 12-month period despite maintenance therapy with a combination of moderate or high-dose ICS and LABA.