FDA to Evaluate Expanded Indication for COPD Drug


Trelegy Ellipta is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist for chronic obstructive pulmonary disease.

After getting the first once-daily, triple-therapy inhaler treatment approved for chronic obstructive pulmonary disease (COPD) approved in the United States months ago, GlaxoSmithKline (GSK) is seeking expanded COPD indications.

Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) (Trelegy Ellipta) was approved in September by the FDA for patients with COPD currently receiving FF/VI (Breo Ellipta) in need of additional bronchodilation, or those receiving Breo Ellipta and UMEC/VI (Incruse Ellipta).

It was a first for the US market, as Trelegy—an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA) combination—broke ground in single, daily use with a triple-drug combination.

But its indication was not a traditional one for patients with COPD, Dr Elaine Jones, Global Medicines Development and the lead for Trelegy, told MD Magazine.

GSK’s supplemental new drug application (sNDA) with the FDA is seeking indication for maintenance treatment of airflow obstruction and reduction of exacerbations in patients with COPD. It is backed by data from the IMPACT study, 10,000-plus patient trial comparing Trelegy to once-daily dual combination therapies FF/VI and UMEC/VI.

With a primary endpoint of reducing annual exacerbations in patients with moderate-to-severe COPD, Trelegy proved efficacy versus the double-therapy drugs, Jones said. It also proved efficacious in secondary endpoints such as change in forced expiratory volume on the first second of breath (FEV1) and change in St. George’s Respiratory Questionnaire (SGRQ) score.

In the study of 10,355 patients, Trelegy reported a 15% reduction in annual on-treatment moderate-to-severe exacerbations versus FF/VI (p<0.001) and 25% reduction versus UMEC/VI (p<0.001).

In what she called an “enormous” study, Jones pointed to the significant p values and added safety results in an important patient group as supplements to a “strong safety stack” submitted to the FDA for indication expansion.

“The medical community is so interested in it because this is first comparison of triple-combination therapy to 2 dual therapies,” Jones said.

COPD, a common pulmonologic disease that frequently occurs in patients at least 40 years old who have been exposed to cigarette smoke, air pollution, chemical fumes, or dust, affects over 380 million people in the world. Despite the improved efficacy of combination therapies, it remains a challenging, progressive disease in patients.

To Jones, COPD care has evolved in the past decade.

“What weve learned is there’s just not one COPD patient — there’s a lot of different genotypes,” Jones said. “Obviously, COPD progresses. Eventually, they end up on triple, because that’s just the nature of the disease.”

This article was originally published by MD Magazine.

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