After Trelegy Ellipta Approval, GSK Looks to More COPD Treatments

Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) became the first once-daily, triple therapy treatment delivered through an inhaler approved for chronic obstructive pulmonary disease (COPD) in the US last week.

The GlaxoSmithKline (GSK) manufactured inhaler was approved specifically by the US Food and Drug Administration (FDA) for patients with COPD including chronic bronchitis and/or emphysema who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations. It is also for COPD patients who need additional treatment of airflow obstructions, or who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

The triple therapy dry powder inhaler was approved in a strength of 100/62.5/25 mg. It is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA).

The accomplishment of an inhaler with 3 combined common therapies that needs only 1 use per day is already substantial. But GSK does not intend to stop there.

Dr. Elaine Jones, Global Medicines Development and the lead for Trelegy, told MD Magazine that GSK is still studying Trelegy, and other COPD treatment avenues.

“GSK has been in inhalation medicine for a very long time,” Jones said. “We are constantly looking for new molecules with which to treat COPD patients.”

Patient perspective played a major role in the development of Trelegy Ellipta. Although treatment has seen evolution over the last decade, COPD is still a debilitating disease generally treated with multiple inhaler therapies every day, Jones said. Three medicines taken in 1 inhalation, once a day alleviates some of the patients’ issues.

“When we spoke to patients — having COPD is very stressful for them and their family,” Jones said. “Taking a therapy that’s not-so-maybe obvious, and having this once a day, it’s just gives them a little more freedom.”

Having now made a breakthrough in expediting the treatment process, GSK researchers are turning to understanding how COPD patients differ, and what the different aspects of COPD are, Jones said.

“People think there are a large number of treatments for COPD, but those treatments have been around for some time,” Jones said. “Are there other molecules out there, are there other medicines out there?”

Part of understanding the disease more — and treating its phenotypes — is addressing the prevalence of smoking, a predominant cause of COPD. As a result, many patients suffer from exacerbations, and have conditions so severe they cannot walk very far, Jones said.

“If a patient has had an exacerbation, their chance of having another greatly increases,” Jones said. “Some patients go for many years without exacerbations — others get many more.”

Getting COPD patients to quit smoking habits through targeted therapies could only help lessen the estimated 11 million patients in the US.

In general, more could be done to better understand and treat the pulmonary disease.

“COPD treatment is not yet complete,” Jones said. “We have many ways to go. We’re always looking for what more we can do.”